Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-000505
    NCT ID: NCT02603146
    Sponsor Protocol Number: ARA08

About this study

The purpose of this study is to determine if hydroxychloroquine is safe and effective for the prevention of a future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Able and willing to give written informed consent and comply with requirements of the study.
  • Age ≥18 years-old at the screening visit.
  • Elevation of autoantibody anti-cyclic citrullinated peptide (anti-CCP) defined by result of anti-CCP ≥40 units, at screening.

Exclusion Criteria:

  • Medical history or current evidence of IA (any type) and/or rheumatic disease and immunologic diseases that may be associated with IA. These diseases include but are not limited to RA, SLE, seronegative spondyloarthropathies (including ankylosing spondylitis, psoriatic arthritis and reactive arthritis), inflammatory bowel disease (including Crohn’s and ulcerative colitis), Sjögren’s syndrome, scleroderma, polymyalgia rheumatica and vasculitis. Patients with mild/moderate crystalline arthropathies do not need to be excluded.
  • Prior or current systemic treatment with DMARDs, immunomodulatory agents, or glucocorticoids for IA or other rheumatic or immunologic diseases.
  • Tetracycline class antibiotic use for autoimmune conditions, taken within 12 months prior to screening. Note: If a tetracycline class antibiotic is used for non-autoimmune conditions, it should be stopped at Day 0/ Randomization visit.
  • Systemic corticosteroid use for non-IA conditions taken 28 days prior to screening.
  • A history of a chronic condition that in the opinion of the investigator is highly likely to require therapy with systemic corticosteroids (oral, intramuscular (IM) or intravenous (IV)) within the study period including but not limited to severe asthma and severe crystalline arthropathy.
  • More than 3 local corticosteroid injections, including but not limited to intra-articular, epidural, and intra-bursal injections, during the 3 months prior to randomization.
  • Women who are pregnant, breastfeeding or desire to become pregnant and/or breast feed within the duration of the 12-month treatment phase of the study.
  • Women of childbearing potential not using or agreeing to use adequate birth control measures (e.g., total abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization, Depo-Provera, or hormonal implants) during the treatment phase of the study.
  • Functional status of NY Heart Association (NYHA) Class III or higher at the screening visit.
  • Medical history of cardiomyopathy, congestive heart failure, or significant cardiac conduction disorders.
  • Medical history of chronic liver disease.
  • Medical history of psoriasis (due to potential for increased risk for flare of skin disease) or porphyria.
  • Medical history or serologic evidence at Screening of chronic infections including, but not limited to, human immunodeficiency virus (HIV), hepatitis B, and untreated hepatitis C.
    • Note: A subject who is Hepatitis C antibody positive will be eligible to participate in the study if he/she has documented treatment of Hepatitis C and documentation of negative hepatitis C viral load post- treatment.
  • History of malignancy within the last 5 years, except for treated basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I.
  • A history of alcohol or substance abuse within 1 year of randomization.
  • Ideal or actual body weight ≤24.4 kg at screening.
  • Any of the following laboratory abnormalities at the screening visit:
    •  Serum creatinine clearance < 50 ml/min (as calculated by the Cockcroft-Gault formula);
    •  Alanine Aminotransferase (ALT) > 2x the upper limit of normal (ULN);
    •  Aspartate Aminotransferase (AST) > 2x the upper limit of normal (ULN);
    •  INR ≥1.25 if not currently taking anticoagulation therapy;
    •  Total white blood count (WBC) < 3.0 x 109/L;
    •  Platelet count ≤150 x109/L;
    •  Hemoglobin < 11 g/dL;
    •  Absolute Neutrophil Count (ANC) < 2.0 x 109/L.
  • Evidence of significant retinal disease upon eye examination during the screening period that in the opinion of the examiner would make identification of potential future retinal toxicity from HCQ difficult to evaluate.
    • Note: Retinal exam results may be applied to evaluations of subject eligibility for up to 6 months after the initial retinal exam.
  • The physician may exclude, for any reason, any subject he/she does not believe would be a good study candidate.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Davis, M.D.

Open for enrollment

Contact information:

Jennifer Sletten

(507)284-3695

Sletten.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20247199

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