Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
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| ClinicalTrials.gov Identifier: NCT01752855 |
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Recruitment Status :
Completed
First Posted : December 19, 2012
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
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Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
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Brief Summary:
A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Biological: New formulation adalimumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 88 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab |
| Study Start Date : | December 2012 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
Drug Information available for:
Adalimumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: New formulation of adalimumab 40 mg every other week
New formulation adalimumab 40 mg every other week
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Biological: New formulation adalimumab
New formulation adalimumab 40 mg every other week
Other Name: Humira |
Primary Outcome Measures :
- Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]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.
- Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48 [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]
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
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≥ 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))
- Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48 [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]
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
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≥ 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))
- Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48 [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 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.
Secondary Outcome Measures :
- Percentage of Participants Positive for Anti-adalimumab Antibody [ Time Frame: Week 24 through Week 48 ]Percentage of participants with anti-adalimumab antibody
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
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If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
- Hormonal contraceptives for 90 days prior to study drug administration;
- A vasectomized partner.
- Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
- Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
- Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
Exclusion Criteria:
- Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
- Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
- Subject plans to use any live vaccine during the study.
- Positive pregnancy test at Baseline (Week 0).
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
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): NCT01752855
Locations
Show 20 study locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Andy Payne, PhD | AbbVie |
Additional Information:
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT01752855 |
| Other Study ID Numbers: |
M13-692 2012-003881-42 ( EudraCT Number ) |
| First Posted: | December 19, 2012 Key Record Dates |
| Results First Posted: | October 29, 2014 |
| Last Update Posted: | October 29, 2014 |
| Last Verified: | October 2014 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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Rheumatoid Arthritis |
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 Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |