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Hydroxychloroquine for Healthy Subjects (StopRA Trial)

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52 and month 36/end of study
Awards & highlights

StopRA Trial Summary

This trial will test whether hydroxychloroquine (HCQ) is safe and effective in preventing rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3).

Eligible Conditions
  • Healthy Subjects
  • Rheumatoid Arthritis

StopRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52 and month 36/end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 and month 36/end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Developed Clinically-Apparent Rheumatoid Arthritis (CL - RA) From Treatment Initiation to Month 36 By Treatment Arm
Secondary outcome measures
Level of Anti-Cyclic Citrullinated Peptide-3 (Anti-CCP3) By Treatment Arm
Level of High-Sensitivity C-Reactive Protein (hsCRP) Treatment Arm
Level of Immunoglobulin M - Rheumatoid Factor (IgM-RF) By Treatment Arm
+11 more

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)

StopRA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hydroxychloroquine GroupExperimental Treatment1 Intervention
Subjects randomized to hydroxychloroquine (HCQ). Subjects will receive 200-400 mg of HCQ (1-2 pills), based upon ideal body weight (IBW), taken daily for 12 months.
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects randomized to placebo HCQ. Subjects will receive 200 - 400 mg of HCQ placebo (1-2 pills), based upon IBW, taken daily for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,988 Total Patients Enrolled
Autoimmunity Centers of ExcellenceOTHER
22 Previous Clinical Trials
1,260 Total Patients Enrolled
Christopher Striebich, MD, PhDStudy ChairUniversity of Colorado School of Medicine
1 Previous Clinical Trials
4 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
UCLA Medical Center: Division of Rheumatology
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis
2016. "Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02603146.
~16 spots leftby Apr 2025
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