Phase 2
N=48
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA)
Bottom Line
View on ClinicalTrials.gov: NCT03823391 ↗Enrolled (actual)
48
Serious AEs
6.4%
Results posted
Jul 2021
Primary outcome: Primary: Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP]) — -2.51; -2.65 score on a scale — p=0.022
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ABBV-3373 (Drug); Placebo for ABBV-3373 (Drug); Adalimumab (Drug); Placebo for adalimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP]) |
-2.51; -2.65 | 0.022 sig |
| SECONDARY Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI) |
-26.30; -27.99 | 0.601 |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) |
-27.42; -28.50 | 0.737 |
| SECONDARY Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR]) |
-2.55; -2.76 | 0.612 |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12 |
58.8; 54.8 | 0.877 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 |
64.7; 51.6 | 0.426 |
Summary
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
Eligibility Criteria
Inclusion Criteria
- Participant has the clinical diagnosis of RA for > 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
- Participant 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 Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein (CRP) >= 3.2 at Screening.
- Participant has an incomplete response to methotrexate. Participants must have been on oral or parental MTX therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.
Exclusion Criteria
- Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.
- Participants previously exposed to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.
Data sourced from ClinicalTrials.gov (NCT03823391). 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.