Phase 1 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old (inclusive).
• People who are able to give written consent to participate.
• Men or women (who are not breastfeeding or pregnant) who have active rheumatoid arthritis (RA), confirmed using recognised international classification criteria.
• People whose RA disease activity score (called CDAI) is above 10, and who have at least 3 tender and at least 3 swollen joints at the screening visit and at the first study day.
• People who are currently taking hydroxychloroquine, methotrexate, or leflunomide may be eligible (confirm with trial site); however, sulfasalazine is not permitted.
• People who have previously taken certain targeted RA medicines (such as tofacitinib or baricitinib) may be eligible, provided those medicines were stopped at least 1 month before the screening visit.
• People taking oral corticosteroids (such as prednisone) may be eligible if they have been on a stable dose of no more than 10 mg per day for at least 4 weeks, and have not received corticosteroid injections (into a muscle, vein, or joint) within 4 weeks before the screening visit.
• People who are biologically capable of having children must agree to use an acceptable method of contraception for the entire study period, and women in this group must have a negative pregnancy test before receiving the study drug.
• People who agree not to receive any vaccinations during the study period (including but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, and others).

Who may not be able to join:

• People who are pregnant (women who are not surgically sterile or at least two years past menopause must have a negative blood pregnancy test within 14 days before receiving the study drug, and a negative urine pregnancy test on the first study day).
• People who are currently breastfeeding.
• People who have an autoimmune disease other than RA, such as psoriasis, lupus, vasculitis, inflammatory bowel disease, Sjögren's syndrome, or certain types of arthritis, or who currently have active fibromyalgia.
• People who have received certain medications too recently, including: rituximab within the past 12 months; abatacept within the past 3 months; infliximab, adalimumab, certolizumab, tocilizumab, cyclosporine, or mycophenolate mofetil within the past 2 months; or etanercept, anakinra, immunoglobulin, or blood products within the past 28 days.
• People who have taken certain immune-affecting therapies (including biologics, JAK inhibitors such as tofacitinib, baricitinib, or upadacitinib, ozanimod, or investigational treatments) without a sufficient washout period before the study start (confirm specific timeframes with trial site).
• People who have a history of, or currently have, an inflammatory joint condition other than RA, such as psoriatic arthritis, gout, reactive arthritis, or Lyme disease.
• People who have signs of active tuberculosis (TB), a history of active TB, or a positive TB test result indicating latent (hidden) TB, including those currently being treated for latent TB.
• People who have had a recent serious infection requiring hospitalisation or intravenous antibiotics within the past 60 days, or any infection requiring oral antibiotics or antivirals within the past 30 days.
• People with a history of long-term or repeated bacterial infections (such as chronic kidney infections or chronic lung disease from infections).
• People who have ever had an infection in a joint replacement or artificial joint.
• People with a history of certain systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidioidomycosis).
• People with a history of more than one episode of shingles, widespread shingles, widespread herpes simplex, or shingles affecting the eye; or whose herpes zoster or herpes simplex symptoms have not fully resolved at least 60 days before screening.
• People with a history of a primary immune system deficiency condition.
• People with a history of HIV infection, or who have tested positive for HIV.
• People who test positive at screening for hepatitis B, hepatitis C, HIV-1, HIV-2, or currently active hepatitis A.
• People who have been diagnosed with cancer in the past 5 years, or who currently have cancer (with some exceptions for certain non-spreading skin cancers or cervical changes in situ — confirm with trial site); or people whose screening tests raised concerns about possible cancer that could not be ruled out.
• People who have a history of or current signs of a demyelinating disorder (a condition affecting the protective coating around nerves, such as multiple sclerosis).
• People with moderate to severe heart failure (classified as New York Heart Association Class III or IV).
• People who have had major surgery within the 60 days before enrolment.
• People for whom fewer than 5 joints can be properly examined for tenderness or swelling (for example, due to past surgery, joint fusion, or amputation).
• People with severe, uncontrolled, or rapidly worsening conditions affecting the kidneys, liver, blood, digestive system, lungs, heart, hormones, nerves, or brain, or who have abnormal blood test results in certain areas including low red blood cell levels, low white blood cell counts, low platelet counts, poor kidney function, significant protein in urine, elevated liver enzyme levels, diagnosed liver cirrhosis, or significant liver scarring (confirm specific thresholds with trial site).
• People who have received any vaccination in the 30 days before the study start (including but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, and others).

Important: Always verify eligibility with the trial site directly before applying.