A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis

Completed

Conditions: rheumatism
rheumatoid arthritis
10023213

Registration Number: NL-OMON48179

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

1. Adult male or female, between 18 and 75 years of age inclusive at Screening.
2. Subject has the clinical diagnosis of RA for > 3 months based on the 1987
ACR classification criteria or 2010 ACR/European League against Rheumatism
(EULAR) criteria.
3. Subject meets the following disease activity criteria: >= 4 swollen joints
(based on 28 joint count) and >= 4 tender joints (based on 28 joint count) at
Screening and BL Visits; and DAS28(CRP) >= 3.2 at Screening.
4. Subject has an incomplete response to MTX. Subjects must have been on oral
or parenteral MTX therapy >= 3 months and on a stable prescription of 15 to 25
mg/week (or >= 10 mg/week in subjects intolerant of MTX at doses >= 15 mg/week)
for >= 4 weeks prior to the first dose of study drug. Subject must be expected
to be able to continue on stable dose of MTX for the duration of study
participation.

Exclusion Criteria

1. Subjects previously exposed to adalimumab or other anti-TNF biologics.
2. Subjects previously exposed to non-anti-TNF biologics or targeted synthetic
DMARDs for RA, with exception of subjects exposed for less than 3 months and
terminated not due to lack of efficacy or intolerability.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in disease activity score (DAS)28 (C-reactive protein [CRP]) from<br /><br>Baseline (BL) at Week 12 for ABBV-3373 and adalimumab.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Change in clinical disease activity index (CDAI) from BL at Week 12 for<br /><br>ABBV-3373 and adalimumab.<br /><br>2. Change in simplified disease activity index (SDAI) from BL at Week 12 for<br /><br>ABBV-3373 and adalimumab.<br /><br>3. Change in DAS28 erythrocyte sedimentation rate [ESR] from BL at Week 12 for<br /><br>ABBV-3373 and adalimumab.<br /><br>4. Proportion of subjects achieving a low disease activity (LDA) (DAS28 [CRP]<br /><br><=3.2) at Week 12 for ABBV-3373 and adalimumab.<br /><br>5. Proportion of subjects achieving American College of Rheumatology (ACR) 50<br /><br>at Week 12 for ABBV-3373 and adalimumab.</p><br>