This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)
- Conditions
- Moderate to Severe Rheumatoid ArthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-005303-39-CZ
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 425
1. Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA.
2. Participant has = 6 swollen joints (based on 66 joint count) and = 6 tender joints (based on 68 joint count) at baseline.
3. Participant must have had an inadequate response to at least one of the following prior b/tsDMARD treatments for RA (or corresponding
biosimilar):
- Tumor necrosis factor inhibitors: adalimumab, certolizumab pegol, etanercept, golimumab, infliximab
- Interleukin-1 receptor inhibitors: anakinra
- Interleukin-6 receptor inhibitors: tocilizumab, sarilumab
- CD20-directed cytolytic antibodies: rituximab
- T cell costimulation modulators: abatacept
- Janus Kinase inhibitors: baricitinib, filgotinib, peficitinib, tofacitinib, upadacitinib
- Investigational drug with positive efficacy data available from confirmatory trials, as agreed with the AbbVie TA MD
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225
1. Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety, tolerability, and efficacy of ABBV-154 administered every other week (eow) and every 4 weeks (e4w) subcutaneously (SC) vs placebo in subjects with moderately to severely active RA with inadequate response to at least one prior b/tsDMARD.;Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics, and immunogenicity of ABBV 154. ;Primary end point(s): Achievement of 50% improvement as measured by American College of Rheumatology response criteria (ACR50) at Week 12.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in Disease Activity Score (DAS) 28 (CRP) from Baseline;<br>2. Change in Clinical Disease Activity Index (CDAI) from Baseline;<br>3. Achievement of ACR20;<br>4. Achievement of ACR70;<br>5. Achievement of Low Disease Activity (LDA) defined by DAS28 (CRP) = 3.2;<br>6. Achievement of LDA defined by CDAI = 10;<br>7. Achievement of clinical remission defined by DAS28 (CRP) < 2.6;<br>8. Achievement of clinical remission defined by CDAI = 2.8; and<br>9. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) from Baseline;Timepoint(s) of evaluation of this end point: Week 12