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Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

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ClinicalTrials.gov Identifier: NCT02433340
Recruitment Status : Completed
First Posted : May 5, 2015
Results First Posted : June 19, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab 40 mg EOW given on background methotrexate.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ABT-122 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-122 120 mg EOW
All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial.
Drug: ABT-122
Other Name: Remtolumab




Primary Outcome Measures :
  1. American College of Rheumatology (ACR) 20 Response Rate at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  2. ACR20 Response Rate at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  3. ACR20 Response Rate at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  4. ACR20 Response Rate at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  5. ACR20 Response Rate at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  6. ACR20 Response Rate at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  7. ACR20 Response Rate at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  8. ACR20 Response Rate at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  9. ACR20 Response Rate at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  10. ACR20 Response Rate at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  11. ACR20 Response Rate at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  12. ACR50 Response Rate at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  13. ACR50 Response Rate at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  14. ACR50 Response Rate at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  15. ACR50 Response Rate at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  16. ACR50 Response Rate at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  17. ACR50 Response Rate at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  18. ACR50 Response Rate at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  19. ACR50 Response Rate at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  20. ACR50 Response Rate at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  21. ACR50 Response Rate at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  22. ACR50 Response Rate at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  23. ACR70 Response Rate at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  24. ACR70 Response Rate at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  25. ACR70 Response Rate at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  26. ACR70 Response Rate at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  27. ACR70 Response Rate at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  28. ACR70 Response Rate at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  29. ACR70 Response Rate at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  30. ACR70 Response Rate at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  31. ACR70 Response Rate at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  32. ACR70 Response Rate at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  33. ACR70 Response Rate at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  34. Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths [ Time Frame: from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks) ]
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.


Secondary Outcome Measures :
  1. Change From Baseline In Tender Joint Count (TJC68) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  2. Change From Baseline in TJC68 at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  3. Change From Baseline in TJC68 at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  4. Change From Baseline in TJC68 at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  5. Change From Baseline in TJC68 at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  6. Change From Baseline in TJC68 at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  7. Change From Baseline in TJC68 at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  8. Change From Baseline in TJC68 at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  9. Change From Baseline in TJC68 at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  10. Change From Baseline in TJC68 at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  11. Change From Baseline in TJC68 at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  12. Change From Baseline in Swollen Joint Count (SJC66) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  13. Change From Baseline in SJC66 at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  14. Change From Baseline in SJC66 at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  15. Change From Baseline in SJC66 at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  16. Change From Baseline in SJC66 at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  17. Change From Baseline in SJC66 at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  18. Change From Baseline in SJC66 at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  19. Change From Baseline in SJC66 at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  20. Change From Baseline in SJC66 at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  21. Change From Baseline in SJC66 at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  22. Change From Baseline in SJC66 at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  23. Change From Baseline in Patient's Assessment of Pain at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  24. Change From Baseline in Patient's Assessment of Pain at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  25. Change From Baseline in Patient's Assessment of Pain at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  26. Change From Baseline in Patient's Assessment of Pain at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  27. Change From Baseline in Patient's Assessment of Pain at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  28. Change From Baseline in Patient's Assessment of Pain at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  29. Change From Baseline in Patient's Assessment of Pain at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  30. Change From Baseline in Patient's Assessment of Pain at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  31. Change From Baseline in Patient's Assessment of Pain at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  32. Change From Baseline in Patient's Assessment of Pain at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  33. Change From Baseline in Patient's Assessment of Pain at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  34. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  35. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  36. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  37. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  38. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  39. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  40. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  41. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  42. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  43. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  44. Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  45. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  46. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  47. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  48. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  49. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  50. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  51. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  52. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  53. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  54. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  55. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  56. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  57. Change From Baseline in HAQ-DI at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  58. Change From Baseline in HAQ-DI at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  59. Change From Baseline in HAQ-DI at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  60. Change From Baseline in HAQ-DI at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  61. Change From Baseline in HAQ-DI at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  62. Change From Baseline in HAQ-DI at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  63. Change From Baseline in HAQ-DI at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  64. Change From Baseline in HAQ-DI at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  65. Change From Baseline in HAQ-DI at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  66. Change From Baseline in HAQ-DI at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  67. Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  68. Change From Baseline in hsCRP at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  69. Change From Baseline in hsCRP at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  70. Change From Baseline in hsCRP at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  71. Change From Baseline in hsCRP at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  72. Change From Baseline in hsCRP at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  73. Change From Baseline in hsCRP at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  74. Change From Baseline in hsCRP at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  75. Change From Baseline in hsCRP at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  76. Change From Baseline in hsCRP at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  77. Change From Baseline in hsCRP at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  78. Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  79. Change From Baseline in DAS28 (hsCRP) at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  80. Change From Baseline in DAS28 (hsCRP) at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  81. Change From Baseline in DAS28 (hsCRP) at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  82. Change From Baseline in DAS28 (hsCRP) at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  83. Change From Baseline in DAS28 (hsCRP) at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  84. Change From Baseline in DAS28 (hsCRP) at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  85. Change From Baseline in DAS28 (hsCRP) at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  86. Change From Baseline in DAS28 (hsCRP) at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  87. Change From Baseline in DAS28 (hsCRP) at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  88. Change From Baseline in DAS28 (hsCRP) at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  89. Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of Tender Joint Count 28 (TJC28) and Swollen Joint Count 28 (SJC28), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  90. Change From Baseline in CDAI at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  91. Change From Baseline in CDAI at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  92. Change From Baseline in CDAI at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  93. Change From Baseline in CDAI at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  94. Change From Baseline in CDAI at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  95. Change From Baseline in CDAI at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  96. Change From Baseline in CDAI at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  97. Change From Baseline in CDAI at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  98. Change From Baseline in CDAI at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  99. Change From Baseline in CDAI at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

  100. Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  101. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  102. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  103. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  104. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  105. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  106. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  107. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  108. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  109. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  110. LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  111. CR Response Rate Per DAS28 (hsCRP) at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  112. CR Response Rate Per DAS28 (hsCRP) at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  113. CR Response Rate Per DAS28 (hsCRP) at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  114. CR Response Rate Per DAS28 (hsCRP) at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  115. CR Response Rate Per DAS28 (hsCRP) at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  116. CR Response Rate Per DAS28 (hsCRP) at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  117. CR Response Rate Per DAS28 (hsCRP) at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  118. CR Response Rate Per DAS28 (hsCRP) at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  119. CR Response Rate Per DAS28 (hsCRP) at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  120. CR Response Rate Per DAS28 (hsCRP) at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  121. CR Response Rate Per DAS28 (hsCRP) at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  122. LDA or CR Response Rate Per CDAI at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  123. LDA or CR Response Rate Per CDAI at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  124. LDA or CR Response Rate Per CDAI at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  125. LDA or CR Response Rate Per CDAI at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  126. LDA or CR Response Rate Per CDAI at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  127. LDA or CR Response Rate Per CDAI at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  128. LDA or CR Response Rate Per CDAI at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  129. LDA or CR Response Rate Per CDAI at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  130. LDA or CR Response Rate Per CDAI at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  131. LDA or CR Response Rate Per CDAI at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  132. LDA or CR Response Rate Per CDAI at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  133. CR Response Rate Per CDAI Criteria at Week 2 [ Time Frame: Week 2 of Study M12-963 ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  134. CR Response Rate Per CDAI Criteria at Week 4 [ Time Frame: Week 4 of Study M12-963 ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  135. CR Response Rate Per CDAI Criteria at Week 6 [ Time Frame: Week 6 of Study M12-963 ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  136. CR Response Rate Per CDAI Criteria at Week 8 [ Time Frame: Week 8 of Study M12-963 ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  137. CR Response Rate Per CDAI Criteria at Week 12 [ Time Frame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965) ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  138. CR Response Rate Per CDAI Criteria at Week 16 [ Time Frame: Week 16 (Week 4 of Study M12-965) ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  139. CR Response Rate Per CDAI Criteria at Week 20 [ Time Frame: Week 20 (Week 8 of Study M12-965) ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  140. CR Response Rate Per CDAI Criteria at Week 24 [ Time Frame: Week 24 (Week 12 of Study M12-965) ]
    Percentage of participants achieving CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  141. CR Response Rate Per CDAI Criteria at Week 28 [ Time Frame: Week 28 (Week 16 of Study M12-965) ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  142. CR Response Rate Per CDAI Criteria at Week 32 [ Time Frame: Week 32 (Week 20 of Study M12-965) ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

  143. CR Response Rate Per CDAI Criteria at Week 36 [ Time Frame: Week 36 (Week 24 of Study M12-965) ]
    Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Subjects who have completed the preceding Study M12-963 (ABT-122) randomized controlled study and have not developed any discontinuation criteria, as defined in Study M12-963.

  • If female, subject must meet one of the following criteria:

    1. Postmenopausal (defined as no menses for at least 1 year).
    2. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
    3. Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug.
  • Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
  • Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
  • Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.

Exclusion Criteria: - Pregnant or breastfeeding female.

  • Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
  • Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
  • Current enrollment in another investigational study; with the exception of Study M12-963, which is required.
  • Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433340


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Paul Peloso, MD AbbVie
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02433340    
Other Study ID Numbers: M12-965
2014-001471-31 ( EudraCT Number )
First Posted: May 5, 2015    Key Record Dates
Results First Posted: June 19, 2017
Last Update Posted: July 24, 2017
Last Verified: June 2017
Keywords provided by AbbVie:
Tolerability
Methotrexate
Safety
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases