Phase 2 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 have given written agreement to take part and are willing to follow the study requirements.
• People aged 18 to 75 years old at the time of signing the consent form.
• People with a body weight of at least 50 kg and a body mass index (a measure of body weight relative to height) between 18.5 and 32.0.
• People who have been diagnosed with rheumatoid arthritis (RA) that started in adulthood, meeting a specific set of international diagnostic standards, for at least 6 months before the screening visit.
• People whose RA is currently active, shown by specific scores on standard disease activity measures, and who have at least 3 swollen joints and at least 3 tender joints at both the screening and baseline visits.
• People who have a blood marker of inflammation (C-reactive protein) above the normal range at screening.
• People whose blood counts are within acceptable levels at both the screening and baseline visits.
• People whose liver and kidney function tests are within acceptable levels at screening.
• People currently taking methotrexate (a common RA medicine) together with folic acid, at a dose within a specified range, for at least 6 months — with at least 3 months at a stable dose.
• People currently taking a TNF inhibitor (a type of biologic RA medicine) for at least 6 months — with at least 3 months at a stable dose — and who have had a partial but not complete response to it, as judged by their doctor.
• People taking hydroxychloroquine (up to 400 mg/day) or low-dose oral steroid (prednisone up to 7.5 mg/day or equivalent), provided the dose has been stable for at least 4 weeks before screening.
• People who have stopped other certain RA medicines at least 2 months before screening (or at least 12 months for cell-depleting therapies such as rituximab).
• Women who could become pregnant must have a negative pregnancy test at screening and again just before the first dose, use highly effective contraception from consent until at least 90 days after the last dose, and not donate eggs during that period.
• Men must use condoms, ensure any partner who could become pregnant uses highly effective contraception, and not donate sperm until at least 90 days after the last dose.

Who may not be able to join:

• People with the most severe classification of RA (Class IV), as defined by standard medical criteria.
• People who have previously been treated with more than one biologic or targeted RA medicine, not counting the TNF inhibitor they are currently taking.
• People whose TNF inhibitor has stopped working because their body has developed antibodies against it, as assessed by the study doctor.
• People who have had a dose change of methotrexate or their TNF inhibitor in the 3 months before the baseline visit, or a dose change of hydroxychloroquine or oral steroids in the 4 weeks before baseline.
• People taking oral steroids at a dose above 7.5 mg/day (or equivalent), or who have received steroid injections into a muscle or vein, in the 4 weeks before baseline.
• People who have had a steroid injection directly into a joint in the 4 weeks before baseline.
• People who have taken any other conventional, biologic, or immunosuppressive RA medicine in the last 2 months.
• People who have received cell-depleting therapy (such as rituximab) in the last 12 months.
• People with certain heart rhythm abnormalities detected on an ECG (heart tracing), including a prolonged electrical interval in the heart above specified limits, or certain types of heart conduction problems.
• People with evidence of a lung condition called interstitial lung disease, regardless of its cause.
• People with a condition that could affect how the body absorbs medicines taken by mouth, such as short bowel syndrome.
• People with certain significant other medical conditions that could interfere with the study, including poorly controlled diabetes or high blood pressure, moderate-to-severe chronic kidney disease, symptomatic heart failure, a heart attack or unstable chest pain within the past 12 months, severe chronic lung disease, or another major inflammatory or connective tissue disease other than RA.
• People with a history of ongoing or recent alcohol misuse, intravenous drug use, or illicit drug use within the past year.
• People with a current or past diagnosis of cancer, with the exception of certain skin cancers that have been fully removed with no signs of spread for at least 3 years.
• People who have had significant surgery within 12 weeks before screening, or who have a major surgery planned during the study period.
• People who have received a BCG vaccine or BCG-based treatment within the past 12 months, any other live vaccine within the past 3 months, or who plan to receive a live vaccine during the study.
• People who have had a serious, opportunistic, chronic, or recurring infection within 3 months of screening, or who develop such an infection before the start of the study (confirm with trial site for specific definitions).
• People with HIV infection, active hepatitis B or C virus infection, or active tuberculosis.
• People with a history of latent tuberculosis infection that has not been fully treated according to international health guidelines (those who have completed a full course of treatment may still be considered — confirm with trial site).
• People with a current or recent active infection, or a fever of 38°C (100.5°F) or above at screening or baseline.
• People with any other serious or uncontrolled medical, surgical, psychiatric, or social condition that the study doctor believes would make participation unsafe or unsuitable.
• People who have taken another experimental medicine within 12 weeks (or at least 5 half-lives of that medicine, whichever is longer) before starting the study drug.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.

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