Phase 1 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from 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 who are not currently taking a biologic or targeted disease-modifying arthritis drug (called a b/tsDMARD), and who have stopped any such drug at least 4 weeks before the study starts (or at least 6 months before, for drugs that deplete B cells, such as rituximab).
• People who have been taking 1 or 2 conventional (non-biologic) arthritis medications at a steady dose for at least 6 weeks, and for at least 12 weeks overall — these may include methotrexate, hydroxychloroquine, chloroquine, sulfasalazine, or leflunomide, within specific dose ranges set by the trial.
• People taking methotrexate who are also taking folic acid or folinic acid supplements at a stable dose.
• People taking low-dose oral steroids (no more than 10 mg prednisone or equivalent per day), provided the dose has been stable for at least 14 days before the study starts.
• People using inhaled steroids for a stable condition, provided the dose has been unchanged for at least 1 week before the first study dose.
• People using anti-inflammatory pain relievers (NSAIDs) or paracetamol (acetaminophen) at a stable dose for at least 1 week before the study starts.
• People who have stopped taking strong opioid pain medications at least 1 week before the study starts.

For one specific group in the trial (Cohort 3) only, the following additional criteria also apply:

• People with moderately to severely active rheumatoid arthritis, defined as having 6 or more tender joints and 6 or more swollen joints, measured at both the screening visit and the first study visit.
• People whose blood test at screening shows a raised level of a marker of inflammation called high-sensitivity C-reactive protein (hsCRP) (confirm with trial site).
• People who have had an inadequate response to, or could not tolerate, at least 1 but no more than 3 biologic or targeted arthritis drugs, covering no more than 2 different ways of working — where "inadequate response" means ongoing or returning disease activity after at least 12 weeks of treatment, and "intolerance" means any documented side effect from the drug when used as directed.
• People whose blood tests show they are positive for anti-CCP antibodies and/or rheumatoid factor (RF) — markers often associated with rheumatoid arthritis.

Who may not be able to join:

• People who have been diagnosed with a widespread muscle or joint disorder that could interfere with study procedures or assessments, as determined by the investigator.
• People with a history of serious opportunistic infection or immune deficiency that the investigator considers a safety risk.
• People with a currently active, clinically significant infection, or those who have needed hospital treatment or intravenous antibiotics for an infection within the past 60 days, or oral antibiotics within the past 30 days.
• People with a history of moderate to severe heart failure (classified as New York Heart Association class III or IV), or who have had this condition in the 6 months before screening.
• People with a history of, or possible current, cancer of the lymph system (lymphoproliferative disease).
• People who have had an organ or bone marrow transplant.
• People who have had major surgery (requiring a nerve block or general anaesthetic) within the 12 weeks before screening, or who have major surgery planned during the study period.
• People who have had a joint replacement or other implanted device that became infected, where the prosthesis or device is still in the body.
• People who have clinically significant heart rhythm abnormalities on their ECG at screening — including a specific heart electrical measurement (QTcF) of more than 450 milliseconds, persistently low potassium levels in the blood (below 3.0 mmol/L), or a family history of a heart rhythm condition called long QT syndrome.
• People who have received a live attenuated vaccine within 4 weeks before the study starts, or who plan to receive one during the study.
• People who have taken part in another clinical drug or device trial within 4 weeks, or within 5 half-lives of that drug (whichever is longer), before screening — and those with prior exposure to investigational biologic drugs should discuss this with the trial sponsor.
• People whose tuberculosis (TB) screening test (IGRA) comes back positive at the screening blood test. People who have previously been fully treated for latent or active TB according to local guidelines may not need this test (confirm with trial site).
• People with evidence of an active hepatitis C virus (HCV) infection — though people who test positive for hepatitis C antibodies but negative for active virus (HCV RNA) may still be considered eligible, at the investigator's discretion, with ongoing monitoring required.
• People whose blood test results at screening fall outside the following ranges (each value may be re-checked once at the investigator's discretion):
  • Haemoglobin (a measure of red blood cells) below 10.0 g/dL
  • White blood cell count below 3.0 x 10³ cells/mm³
  • Neutrophil count (infection-fighting white blood cells) below 1.5 x 10³ cells/mm³
  • Lymphocyte count (another type of immune cell) below 1.0 x 10³ cells/mm³
  • Platelet count (cells involved in clotting) below 100 x 10³ cells/mm³
  • Liver enzyme levels (ALT or AST) at 1.5 times or more above the normal upper limit
  • Total bilirubin (a liver marker) at 2 times or more above the normal upper limit, unless the person has a documented diagnosis of Gilbert's disease
  • Kidney function (creatinine clearance) below 50 mL/min, calculated using a standard formula

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