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NCT02603146 · ClinicalTrials.gov registry record · Phase 2
Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
NCT02603146: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02603146 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 144 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02603146, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3). The following recruitment strategies will be employed towards identifying healthy subjects with elevated anti-cyclic citrullinated peptide (anti-CCP3) levels: -Pre-screening: * first degree relatives of patients with rheumatoid arthritis (RA); * subjects at health-fairs; and * identification of subjects with elevated anti-CCP3 levels in the absence of inflammatory arthritis in rheumatology clinics.
Primary Outcome
Clinically-Apparent RA is defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria as either: 1.) a score of ≥ 6 defining "definite RA" or 2.) a joint examination consistent with Inflammatory Arthritis (IA) with ≥ 1 erosion confirmed by x-ray imaging of the hands, wrists, and feet.
Interventions
- DRUG Hydroxychloroquine
- DRUG HCQ Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2016-04-27 |
| Est. Completion | 2022-11-01 |
| Phase | Phase 2 |
Why NCT02603146 stopped before completion
NCT02603146 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Hydroxychloroquine is the first listed.
NCT02603146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02603146 about?
NCT02603146 is a clinical study titled "Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis". The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3). The following recruitment strategies will...
What is the current status of trial NCT02603146?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2016-04-27. Estimated completion is 2022-11-01.
What interventions are being tested in trial NCT02603146?
The interventions under investigation include: Hydroxychloroquine (DRUG), HCQ Placebo (DRUG).
Who is sponsoring clinical trial NCT02603146?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02603146's enrollment target sits among peer trials
144 500th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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