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NCT03823391 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
A Phase 2 study of Rheumatoid Arthritis (RA), sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT03823391: Completed Phase 2 study of Rheumatoid Arthritis (RA), sponsored by AbbVie.
NCT03823391 is a Phase 2 study of Rheumatoid Arthritis (RA) that has completed, run by AbbVie. The registered enrollment target is 48 participants, below the 265-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03823391, a Phase 2 study of Rheumatoid Arthritis (RA), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (C
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG ABBV-3373
- DRUG Placebo for ABBV-3373
- DRUG Placebo for adalimumab
Study Locations (20)
Florida
- Suncoast Clinical Research /ID# 213973 - New Port Richey
- Arthritis Center, Inc. /ID# 213972 - Palm Harbor
- W. Broward Rheum Assoc Inc. /ID# 211017 - Tamarac
- BayCare Medical Group, Inc. /ID# 213935 - Tampa
California
- C.V. Mehta MD, Med Corporation /ID# 213068 - Hemet
- Robin K. Dore MD, Inc /ID# 213045 - Tustin
- Inland Rheum & Osteo Med Grp /ID# 213044 - Upland
Ohio
- Paramount Medical Research Con /ID# 209042 - Middleburg Heights
- STAT Research, Inc. /ID# 213933 - Vandalia
Texas
- PCCR Solution /ID# 215457 - Colleyville
- Trinity Universal Research Association /ID# 209167 - Plano
Alabama
- Rheum Assoc of North Alabama /ID# 213626 - Huntsville
Arizona
- AZ Arthritis and Rheum Researc /ID# 208515 - Phoenix
Idaho
- Institute of Arthritis Researc /ID# 213043 - Idaho Falls
Kansas
- PRN Professional Research Network of Kansas, LLC /ID# 213046 - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2020-08-26 |
| Phase | Phase 2 |
What the finished NCT03823391 record still lists
NCT03823391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 265-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Rheumatoid Arthritis (RA) appearing as the primary indexed condition, and to 4 interventions - of which Adalimumab is the first listed.
NCT03823391 names 20 study sites across 13 states, led by Florida, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT03823391 about?
NCT03823391 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)". 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.
What is the current status of trial NCT03823391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2019-03-27. Estimated completion is 2020-08-26.
What conditions does trial NCT03823391 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis (RA).
What interventions are being tested in trial NCT03823391?
The interventions under investigation include: Adalimumab (DRUG), ABBV-3373 (DRUG), Placebo for ABBV-3373 (DRUG), Placebo for adalimumab (DRUG).
Who is sponsoring clinical trial NCT03823391?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03823391 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03823391's enrollment target sits among peer trials
48 15th of 17 higher than 3 of 17 other Rheumatoid Arthritis (RA) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis (RA) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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