Phase IIIB Subcutaneous Missed Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00533897
First received: September 20, 2007
Last updated: April 22, 2015
Last verified: April 2015
Results First Received: January 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Abatacept
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with Rheumatoid Arthritis (American College of Rheumatology Class I, II or III) were enrolled. Study initiated November 2007. Short Term (ST) results and some long term extension (LTE) results up to a database lock in 2010 were released earlier. Study concluded February 2014. Final LTE results are now included.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
270 participants enrolled; 167 were treated in the Short Term (ST) study. 103 were not treated (10 withdrew consent, 2 lost to follow-up, 91 no longer met study criteria). ST study included 3 Periods: Lead-In (LI), Doubleblind Withdrawal (DBW), and Reintroduction (RI).150 participants entered the LTE study.

Reporting Groups
  Description
Abatacept (ABA) [Lead-In (LI)] On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
Abatacept (ABA) Double-blind Withdrawal (DBW) After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
Placebo (PLA) Double Blind Withdrawal (DBW) After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
ABA With IV PLA Loading Dose in Re-introduction (RI) Period After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
PLA Switched to ABA With ABA IV Loading Dose in RI Period After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
PLA Switched to ABA With PLA IV Loading Dose in RI Period After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
Long Term Extension Abatacept for LI Period Non-responders Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
Long Term Extension (LTE) Abatacept for Short Term Completers Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).

Participant Flow for 4 periods

Period 1:   Lead-in (LI) Period 1
    Abatacept (ABA) [Lead-In (LI)]     Abatacept (ABA) Double-blind Withdrawal (DBW)     Placebo (PLA) Double Blind Withdrawal (DBW)     ABA With IV PLA Loading Dose in Re-introduction (RI) Period     PLA Switched to ABA With ABA IV Loading Dose in RI Period     PLA Switched to ABA With PLA IV Loading Dose in RI Period     Long Term Extension Abatacept for LI Period Non-responders     Long Term Extension (LTE) Abatacept for Short Term Completers  
STARTED     167     0     0     0     0     0     0     0  
COMPLETED     157 [1]   0     0     0     0     0     0     0  
NOT COMPLETED     10     0     0     0     0     0     0     0  
Adverse Event                 1                 0                 0                 0                 0                 0                 0                 0  
Participant Withdrew Consent                 2                 0                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 1                 0                 0                 0                 0                 0                 0                 0  
Administrative Reason By Sponsor                 2                 0                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 3                 0                 0                 0                 0                 0                 0                 0  
Missed 2 Consecutive Doses of Study Drug                 1                 0                 0                 0                 0                 0                 0                 0  
[1] 37 participants entered the LTE directly and did not enter the DBW Period nor receive DBW treatment.

Period 2:   Double-blind Withdrawal (DBW) Period 2
    Abatacept (ABA) [Lead-In (LI)]     Abatacept (ABA) Double-blind Withdrawal (DBW)     Placebo (PLA) Double Blind Withdrawal (DBW)     ABA With IV PLA Loading Dose in Re-introduction (RI) Period     PLA Switched to ABA With ABA IV Loading Dose in RI Period     PLA Switched to ABA With PLA IV Loading Dose in RI Period     Long Term Extension Abatacept for LI Period Non-responders     Long Term Extension (LTE) Abatacept for Short Term Completers  
STARTED     0     40     80     0     0     0     0     0  
COMPLETED     0     39 [1]   77 [2]   0     0     0     0     0  
NOT COMPLETED     0     1     3     0     0     0     0     0  
Lack of Efficacy                 0                 1                 2                 0                 0                 0                 0                 0  
Poor/Non-Compliance                 0                 0                 1                 0                 0                 0                 0                 0  
[1] One participant discontinued the DBW Period due to Lack of Efficacy to enter the RI Period early
[2] Two participants discontinued the DBW Period due to Lack of Efficacy to enter the RI Period early

Period 3:   Re-introduction (RI) Period 3
    Abatacept (ABA) [Lead-In (LI)]     Abatacept (ABA) Double-blind Withdrawal (DBW)     Placebo (PLA) Double Blind Withdrawal (DBW)     ABA With IV PLA Loading Dose in Re-introduction (RI) Period     PLA Switched to ABA With ABA IV Loading Dose in RI Period     PLA Switched to ABA With PLA IV Loading Dose in RI Period     Long Term Extension Abatacept for LI Period Non-responders     Long Term Extension (LTE) Abatacept for Short Term Completers  
STARTED     0     0     0     40 [1]   35 [1]   44 [1]   0     0  
COMPLETED     0     0     0     40     35     42     0     0  
NOT COMPLETED     0     0     0     0     0     2     0     0  
Participant Withdrew Consent                 0                 0                 0                 0                 0                 1                 0                 0  
No Longer Meets Study Criteria                 0                 0                 0                 0                 0                 1                 0                 0  
[1] 1 participant discontinued the DBW Period due to Lack of Efficacy to enter RI Period early

Period 4:   Long Term Extension (LTE)
    Abatacept (ABA) [Lead-In (LI)]     Abatacept (ABA) Double-blind Withdrawal (DBW)     Placebo (PLA) Double Blind Withdrawal (DBW)     ABA With IV PLA Loading Dose in Re-introduction (RI) Period     PLA Switched to ABA With ABA IV Loading Dose in RI Period     PLA Switched to ABA With PLA IV Loading Dose in RI Period     Long Term Extension Abatacept for LI Period Non-responders     Long Term Extension (LTE) Abatacept for Short Term Completers  
STARTED     0     0     0     0     0     0     37 [1]   113 [2]
COMPLETED     0     0     0     0     0     0     24 [3]   88 [3]
NOT COMPLETED     0     0     0     0     0     0     13     25  
Participant Withdrew Consent                 0                 0                 0                 0                 0                 0                 2                 5  
Death                 0                 0                 0                 0                 0                 0                 1                 3  
Lack of Efficacy                 0                 0                 0                 0                 0                 0                 5                 3  
Poor/Non-compliance                 0                 0                 0                 0                 0                 0                 1                 0  
Adverse Event                 0                 0                 0                 0                 0                 0                 2                 5  
Pregnancy                 0                 0                 0                 0                 0                 0                 0                 2  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 1                 1  
not specified                 0                 0                 0                 0                 0                 0                 1                 6  
[1] 37 non-responders in Lead-In entered the LTE directly and didn't participate in DBW or RI Periods.
[2] 117 completed RI but 4 did not enter LTE: 1 lack of efficacy and 3 had their site closed.
[3] Participant continued until SC ABA was available in respective country or Sponsor ended study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Period 1 Non-responders and Period 2 participants who received at least one dose of abatacept during the study were summarized.

Reporting Groups
  Description
Period 1 Non-Responders Participants received abatacept (ABA) intravenous (IV) loading dose and subcutaneous (SC) injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 non-responders skipped Periods 2 and 3 and entered the long term extension (LTE).
Abatacept Received in Period 2 Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to ABA (Day 85-169).
Placebo Received in Period 2 Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to Placebo (Day 85-169).
Total Total of all reporting groups

Baseline Measures
    Period 1 Non-Responders     Abatacept Received in Period 2     Placebo Received in Period 2     Total  
Number of Participants  
[units: participants]
  37     40     80     157  
Age  
[units: years]
Mean (Standard Deviation)
  53.4  (12.7)     48.9  (14.2)     49.1  (12.8)     49.8  (13.1)  
Gender  
[units: participants]
       
Female     30     34     67     131  
Male     7     6     13     26  



  Outcome Measures
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1.  Primary:   Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169   [ Time Frame: Day 169 ]

2.  Primary:   Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups   [ Time Frame: Day 253 (short term) ]

3.  Secondary:   RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group   [ Time Frame: Day 253 (short term) ]

4.  Secondary:   Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time   [ Time Frame: For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

5.  Secondary:   LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time   [ Time Frame: For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

6.  Secondary:   DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time   [ Time Frame: Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period ]

7.  Secondary:   DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits   [ Time Frame: Day 22 after last dose of drug to Day 85 after last dose of drug ]

8.  Secondary:   DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time   [ Time Frame: Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period ]

9.  Secondary:   DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits   [ Time Frame: Day 22 after last dose of drug to Day 85 after last dose of drug ]

10.  Secondary:   RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group   [ Time Frame: For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

11.  Secondary:   RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group   [ Time Frame: For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

12.  Secondary:   Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups   [ Time Frame: For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug ]

13.  Secondary:   Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups   [ Time Frame: For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug ]

14.  Secondary:   Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups   [ Time Frame: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term) ]

15.  Secondary:   Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups   [ Time Frame: Days 85, 169, and 253 (short term) ]

16.  Secondary:   Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups   [ Time Frame: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term) ]

17.  Secondary:   Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups   [ Time Frame: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term) ]

18.  Secondary:   LI; Mean Change in DAS 28 (CRP) From Baseline Over Time   [ Time Frame: Days 1 (Baseline), 15, 29, 57, 78, 85 ]

19.  Secondary:   LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time   [ Time Frame: Days 15, 29, 57, 78, 85 ]

20.  Secondary:   DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time   [ Time Frame: Days 85 (Period 2 Baseline), 113, 141, and 169 ]

21.  Secondary:   DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time   [ Time Frame: Days 85, 113, 141, and 169 ]

22.  Secondary:   RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time   [ Time Frame: Days 169 (Period III Baseline), 197, 225, and 253 ]

23.  Secondary:   LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation   [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

24.  Secondary:   LI Period; Number of Participants With AEs of Special Interest   [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

25.  Secondary:   LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria   [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

26.  Secondary:   LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

27.  Secondary:   LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

28.  Secondary:   LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

29.  Secondary:   LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Days 1, 15, 29, 57, 78, and 85 ]

30.  Secondary:   LI Period; Mean Heart Rate (HR)   [ Time Frame: Days 1, 15, 29, 57, 78, and 85 ]

31.  Secondary:   LI Period; Mean Temperature (T)   [ Time Frame: Days 1, 15, 29, 57, 78, and 85 ]

32.  Secondary:   DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation   [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

33.  Secondary:   DBW; Number of Participants With AEs of Special Interest   [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

34.  Secondary:   DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

35.  Secondary:   DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

36.  Secondary:   DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

37.  Secondary:   DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

38.  Secondary:   DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period   [ Time Frame: Days 113, 141, and 169 ]

39.  Secondary:   DBW Period; Mean Heart Rate (HR) During Period 2   [ Time Frame: Days 113, 141, and 169 ]

40.  Secondary:   DBW Period; Mean Temperature (T) During Period II   [ Time Frame: Days 113, 141, and 169 ]

41.  Secondary:   RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation   [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

42.  Secondary:   RI; Number of Participants With AEs of Special Interest   [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

43.  Secondary:   RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

44.  Secondary:   RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

45.  Secondary:   RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

46.  Secondary:   RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria   [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

47.  Secondary:   RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III   [ Time Frame: Days 169, 197, 225, and 253 ]

48.  Secondary:   RI Period; Mean Heart Rate (HR) During Period III   [ Time Frame: Days 169, 197, 225, and 253 ]

49.  Secondary:   RI Period; Mean Temperature (T) During Period III   [ Time Frame: Days 169, 197, 225, and 253 ]

50.  Secondary:   Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups   [ Time Frame: Day 197 through Day 253 ]

51.  Secondary:   Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups   [ Time Frame: Day 197 through Day 253 ]

52.  Secondary:   ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups   [ Time Frame: Baseline, Day 253 ]

53.  Secondary:   LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE   [ Time Frame: For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821. ]

54.  Secondary:   LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE   [ Time Frame: For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821 ]

55.  Secondary:   LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE   [ Time Frame: For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821. ]

56.  Secondary:   LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE   [ Time Frame: Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073 ]

57.  Secondary:   LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE   [ Time Frame: Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTE ]

58.  Secondary:   LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)   [ Time Frame: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose. ]

59.  Secondary:   LTE: Number of Participants With AEs of Special Interest During LTE   [ Time Frame: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose. ]

60.  Secondary:   LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE   [ Time Frame: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. ]

61.  Secondary:   LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE   [ Time Frame: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. ]

62.  Secondary:   LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE   [ Time Frame: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. ]

63.  Secondary:   LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE   [ Time Frame: For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose. ]

64.  Secondary:   LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE   [ Time Frame: Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073 ]

65.  Secondary:   LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE   [ Time Frame: Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073 ]

66.  Secondary:   LTE: Mean Heart Rate (HR) During LTE   [ Time Frame: Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073 ]

67.  Secondary:   LTE: Mean Temperature (T) During LTE   [ Time Frame: Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00533897     History of Changes
Other Study ID Numbers: IM101-167
Study First Received: September 20, 2007
Results First Received: January 10, 2011
Last Updated: April 22, 2015
Health Authority: United States: Food and Drug Administration