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Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis

NCT02603146 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-06-12

Study results available
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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.

Conditions

  • Healthy Participants
  • Rheumatoid Arthritis (RA) Prevention

Interventions

DRUG

Hydroxychloroquine

As described. Dosing will be based upon Screening IBW.

DRUG

HCQ Placebo

As described. Dosing will be based upon Screening IBW.

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kevin Deane, MD, PhD · University of Colorado School of Medicine

  • Michael Holers, MD · University of Colorado School of Medicine

  • Christopher Striebich, MD, PhD · University of Colorado School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-27
Primary Completion
2022-11-01
Completion
2022-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603146 on ClinicalTrials.gov