Trial Outcomes & Findings for Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab (NCT NCT01752855)

NCT ID: NCT01752855

Last Updated: 2014-10-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 88 participants
• Primary outcome timeframe: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
• Results posted on: 2014-10-29

Participant Flow

Participant milestones

Measure	New Formulation for 48 Weeks 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 for 24 Weeks, New Formulation for 24 Weeks 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 Study STARTED	44	44
Overall Study COMPLETED	43	40
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	New Formulation for 48 Weeks 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 for 24 Weeks, New Formulation for 24 Weeks 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 Study Adverse Event	1	0
Overall Study Withdrew Consent	0	2
Overall Study Lack of Efficacy	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	New Formulation for 48 Weeks n=44 Participants 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 for 24 Weeks, New Formulation for 24 Weeks n=44 Participants 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 n=88 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 10.8 • n=5 Participants	52.0 years STANDARD_DEVIATION 12.0 • n=7 Participants	53.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Population: 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.

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.

Outcome measures

Measure	New Formulation for 48 Weeks n=44 Participants 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 for 24 Weeks, New Formulation for 24 Weeks n=44 Participants 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
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 Week 36	-2.4 units on a scale Standard Deviation 1.17	-2.2 units on a scale Standard Deviation 1.05
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 Week 48	-2.4 units on a scale Standard Deviation 1.29	-2.2 units on a scale Standard Deviation 1.28

PRIMARY outcome

Timeframe: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Population: All participants who received at least one dose of study drug.

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))

Outcome measures

Measure	New Formulation for 48 Weeks n=44 Participants 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 for 24 Weeks, New Formulation for 24 Weeks n=44 Participants 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
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48 Week 48	74.4 percentage of participants	80.0 percentage of participants
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48 Week 36	72.7 percentage of participants	76.7 percentage of participants

PRIMARY outcome

Timeframe: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Population: All participants who received at least one dose of study drug.

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))

Outcome measures

Measure	New Formulation for 48 Weeks n=44 Participants 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 for 24 Weeks, New Formulation for 24 Weeks n=44 Participants 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
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48 Week 36	50.0 percentage of participants	51.2 percentage of participants
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48 Week 48	53.5 percentage of participants	57.5 percentage of participants

PRIMARY outcome

Timeframe: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Population: 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.

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.

Outcome measures

Measure	New Formulation for 48 Weeks n=44 Participants 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 for 24 Weeks, New Formulation for 24 Weeks n=43 Participants 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
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48 Week 36	-0.5 units on a scale Standard Deviation 0.60	-0.5 units on a scale Standard Deviation 0.69
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48 Week 48	-0.5 units on a scale Standard Deviation 0.57	-0.5 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Week 24 through Week 48

Population: All participants who received at least one dose of study drug.

Percentage of participants with anti-adalimumab antibody

Outcome measures

Measure	New Formulation for 48 Weeks n=44 Participants 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 for 24 Weeks, New Formulation for 24 Weeks n=44 Participants 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
Percentage of Participants Positive for Anti-adalimumab Antibody	13.6 percentage of participants	18.2 percentage of participants

Adverse Events

New Formulation for 48 Weeks

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Current Formulation for 24 Weeks, New Formulation for 24 Weeks

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	New Formulation for 48 Weeks n=44 participants at risk 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 for 24 Weeks, New Formulation for 24 Weeks n=44 participants at risk 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
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	2.3% 1/44 • 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.	0.00% 0/44 • 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.
Cardiac disorders ATRIAL FIBRILLATION	2.3% 1/44 • 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.	0.00% 0/44 • 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.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	2.3% 1/44 • 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.	2.3% 1/44 • 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.

Other adverse events

Measure	New Formulation for 48 Weeks n=44 participants at risk 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 for 24 Weeks, New Formulation for 24 Weeks n=44 participants at risk 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
Gastrointestinal disorders DYSPEPSIA	6.8% 3/44 • 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.	6.8% 3/44 • 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.
Infections and infestations CYSTITIS	9.1% 4/44 • 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.	4.5% 2/44 • 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.
Infections and infestations NASOPHARYNGITIS	13.6% 6/44 • 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.	15.9% 7/44 • 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.
Infections and infestations ORAL HERPES	6.8% 3/44 • 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.	4.5% 2/44 • 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.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.1% 4/44 • 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.	9.1% 4/44 • 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.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	4.5% 2/44 • 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.	6.8% 3/44 • 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.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/44 • 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.	6.8% 3/44 • 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.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	6.8% 3/44 • 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.	9.1% 4/44 • 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.
Nervous system disorders HEADACHE	6.8% 3/44 • 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.	6.8% 3/44 • 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.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER