Phase 2
Completed N=88
Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
Source: ClinicalTrials.gov NCT01752855 ↗Enrolled (actual)
88
Serious AEs
3.4%
Results posted
Oct 2014
Primary outcomePrimary: Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 — -2.4; -2.2; -2.4; -2.2 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 |
-2.4; -2.2; -2.4; -2.2 | — |
| PRIMARY Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48 |
72.7; 76.7; 74.4; 80.0 | — |
| PRIMARY Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48 |
50.0; 51.2; 53.5; 57.5 | — |
| PRIMARY Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48 |
-0.5; -0.5; -0.5; -0.5 | — |
| SECONDARY Percentage of Participants Positive for Anti-adalimumab Antibody |
13.6; 18.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
- 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.
Data sourced from ClinicalTrials.gov (NCT01752855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.