A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
- Conditions
- Moderate to Severe Rheumatoid ArthritisMedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-003053-21-PL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To assess the safety, tolerability, and efficacy of ABBV-3373 administered every other week (eow) intravenously (IV) in subjects with moderately to severely active RA on background MTX.<br>2. To compare clinical efficacy of ABBV-3373 with adalimumab and to test the concept that an anti-TNF antibody-drug-conjugate has the potential to provide superior efficacy than the traditional anti-TNF antibody in RA.;Secondary Objective: 3. To compare adalimumab with synthetic control to establish assay sensitivity.<br>4. To assess the pharmacokinetics (PK), pharmacodynamics and immunogenicity of ABBV-3373.<br>5. To assess the durability of the treatment effect of ABBV-3373 after discontinuation.<br>;Primary end point(s): The change in disease activity score (DAS)28 (C-reactive protein [CRP]) from Baseline (BL) at Week 12 for ABBV-3373 and adalimumab.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in clinical disease activity index (CDAI) from BL at Week 12 for ABBV-3373 and adalimumab.<br>2. Change in simplified disease activity index (SDAI) from BL at Week 12 for ABBV-3373 and adalimumab.<br>3. Change in DAS28 erythrocyte sedimentation rate [ESR] from BL at Week 12 for ABBV-3373 and adalimumab.<br>4. Proportion of subjects achieving a low disease activity (LDA) (DAS28 [CRP] =3.2) at Week 12 for ABBV-3373 and adalimumab.<br>5. Proportion of subjects achieving American College of Rheumatology (ACR) 50 at Week 12 for ABBV-3373 and adalimumab.;Timepoint(s) of evaluation of this end point: Week 12