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Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

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ClinicalTrials.gov Identifier: NCT01752855
Recruitment Status : Completed
First Posted : December 19, 2012
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: New formulation adalimumab
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Hide Arm/Group Description New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Period Title: Overall Study
Started 44 44
Completed 43 40
Not Completed 1 4
Reason Not Completed
Adverse Event             1             0
Withdrew Consent             0             2
Lack of Efficacy             0             2
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks Total
Hide Arm/Group Description New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week Total of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 88 participants
55.7  (10.8) 52.0  (12.0) 53.9  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
37
  84.1%
37
  84.1%
74
  84.1%
Male
7
  15.9%
7
  15.9%
14
  15.9%
1.Primary Outcome
Title Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
Hide Description The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Time Frame Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were included. If a participant did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Hide Arm/Group Description:
New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 36 -2.4  (1.17) -2.2  (1.05)
Week 48 -2.4  (1.29) -2.2  (1.28)
2.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
Hide Description

American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

  • ≥ 20% improvement in tender joint count;
  • ≥ 20% improvement in swollen joint count; and
  • ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Time Frame Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Hide Arm/Group Description:
New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Overall Number of Participants Analyzed 44 44
Measure Type: Number
Unit of Measure: percentage of participants
Week 36 72.7 76.7
Week 48 74.4 80.0
3.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
Hide Description

American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

  • ≥ 50% improvement in tender joint count;
  • ≥ 50% improvement in swollen joint count; and
  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Time Frame Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Hide Arm/Group Description:
New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Overall Number of Participants Analyzed 44 44
Measure Type: Number
Unit of Measure: percentage of participants
Week 36 50.0 51.2
Week 48 53.5 57.5
4.Primary Outcome
Title Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
Hide Description The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.
Time Frame Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Data from participants receiving the new formulation of adalimumab in Study NCT01712178 were analyzed for 44 and 43 participants, respectively, at weeks 36 and 48. Data for the participants receiving the current formulation of adalimumab in Study NCT01712178 were analyzed for 43 participants at week 36 and 40 participants at week 48.
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Hide Arm/Group Description:
New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 36 -0.5  (0.60) -0.5  (0.69)
Week 48 -0.5  (0.57) -0.5  (0.58)
5.Secondary Outcome
Title Percentage of Participants Positive for Anti-adalimumab Antibody
Hide Description Percentage of participants with anti-adalimumab antibody
Time Frame Week 24 through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Hide Arm/Group Description:
New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
Overall Number of Participants Analyzed 44 44
Measure Type: Number
Unit of Measure: percentage of participants
13.6 18.2
Time Frame Adverse events were collected from the time of study drug administration until 70 days following the last dose, approximately 58 weeks. Serious adverse events were collected from the time the participant signed the informed consent.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Hide Arm/Group Description New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week. Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
All-Cause Mortality
New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   2/44 (4.55%)   1/44 (2.27%) 
Blood and lymphatic system disorders     
IRON DEFICIENCY ANAEMIA  1  1/44 (2.27%)  0/44 (0.00%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  1/44 (2.27%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders     
OSTEOARTHRITIS  1  1/44 (2.27%)  1/44 (2.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
New Formulation for 48 Weeks Current Formulation for 24 Weeks, New Formulation for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   18/44 (40.91%)   19/44 (43.18%) 
Gastrointestinal disorders     
DYSPEPSIA  1  3/44 (6.82%)  3/44 (6.82%) 
Infections and infestations     
CYSTITIS  1  4/44 (9.09%)  2/44 (4.55%) 
NASOPHARYNGITIS  1  6/44 (13.64%)  7/44 (15.91%) 
ORAL HERPES  1  3/44 (6.82%)  2/44 (4.55%) 
UPPER RESPIRATORY TRACT INFECTION  1  4/44 (9.09%)  4/44 (9.09%) 
Investigations     
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/44 (4.55%)  3/44 (6.82%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  0/44 (0.00%)  3/44 (6.82%) 
RHEUMATOID ARTHRITIS  1  3/44 (6.82%)  4/44 (9.09%) 
Nervous system disorders     
HEADACHE  1  3/44 (6.82%)  3/44 (6.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01752855     History of Changes
Other Study ID Numbers: M13-692
2012-003881-42 ( EudraCT Number )
First Submitted: December 17, 2012
First Posted: December 19, 2012
Results First Submitted: October 22, 2014
Results First Posted: October 29, 2014
Last Update Posted: October 29, 2014