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 are able to understand the study and are willing to sign a written consent form
• People who are enrolled in a related companion study (protocol 15-D-0051) about diseases involving the salivary glands
• People who are willing to follow all study procedures and are available for the full duration of the study
• Adults between 18 and 75 years old (male or female)
• People who are in generally good health based on their medical history
• People who have been diagnosed with Sjögren's disease using recognised medical classification systems, with mild to moderate disease activity based on a specific scoring tool (called ESSDAI, with a score between 0 and 13 at the screening visit), and who still produce some saliva
• People who are able to swallow tablets and are willing to follow the study medication schedule
• People taking steroid medications (such as prednisone), provided the daily dose is less than 10 mg and has been at the same level for at least 4 weeks before the screening visit
• People taking antimalarial medications such as hydroxychloroquine, chloroquine, or quinacrine, provided the dose has been stable for at least 12 weeks before screening and does not exceed the maximum doses specified in the trial (confirm with trial site for exact dose limits)
• People taking cholesterol-lowering medications, provided these were started at least 3 months before the screening visit and the dose has been stable for at least 4 weeks before joining
• People of reproductive potential who agree to use effective birth control methods throughout the study, as documented by a clinician (confirm with trial site for accepted methods)
• People who agree to follow lifestyle guidelines for the duration of the study
• Participants who previously received a placebo in a related earlier trial (20-D-0131) may also be invited to take part

Who may not be able to join:

• People who have been treated with rituximab, belimumab, or other biologic medicines in the 6 months before screening
• People who have previously taken Tofacitinib for more than 6 months within the last 2 years before screening
• People currently taking certain immune-suppressing medicines such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or similar drugs — unless these were stopped at least 8 weeks before the screening visit (note: eye drops or skin creams containing these medicines are allowed)
• People who have been treated with cyclophosphamide, high-dose methylprednisolone injections, or IVIG within the 6 months before screening
• People currently taking certain medications that affect how Tofacitinib is processed by the body, such as ketoconazole or fluconazole (confirm with trial site for full list)
• People with a history of significant chronic liver disease (not including well-controlled Sjögren's-related liver disease), or who have abnormal liver function test results at screening above levels specified by the trial
• People with a blood creatinine level above 1.5 mg/dL, indicating reduced kidney function
• People with certain levels of protein in their urine, as measured by specific tests at screening
• People with signs of active kidney inflammation detected in a urine test
• People with high cholesterol or high triglyceride levels on a fasting blood test taken within 45 days of the screening visit, above the levels specified by the trial
• People with certain abnormal blood counts at screening, including low white blood cells, low red blood cells (anaemia), low platelets, or low lymphocyte levels below the thresholds specified by the trial
• Women who are pregnant or breastfeeding, or women of childbearing potential who have a positive pregnancy test at screening
• People with a history of drug or alcohol misuse in the 6 months before screening
• People currently receiving any form of dialysis (kidney or intestinal)
• People with an active infection requiring antibiotic treatment that has not resolved at least 14 days before the first study dose
• People with ongoing chronic infections, including HIV, Hepatitis B, Hepatitis C, or BK virus detected at screening
• People with a current or past diagnosis of cancer, except for certain types of fully treated skin cancer or cervical cancer in situ as specified by the trial
• People with known active tuberculosis (TB); people with untreated latent TB will be assessed individually by an infectious disease specialist and may still be considered eligible (confirm with trial site)
• People with a history of severe or unusual infections
• People with active kidney disease or active central nervous system disease, or very high disease activity in any organ system other than the joints, as measured by the ESSDAI scoring tool
• People with known risk factors for serious heart events, including a history of heart attack, heart failure, cardiomyopathy, severe heart valve disease, significant abnormal heart rhythms, chronic kidney failure, stroke or mini-stroke, uncontrolled diabetes, uncontrolled high blood pressure, or people who currently smoke or stopped smoking less than 3 years ago and/or have a significant smoking history
• People with significant impairment of major organs (lung, heart, liver, or kidney), or any condition the study doctor believes would put the person at risk from taking Tofacitinib
• People with a known history of blood clots (in arteries or veins) or who are considered at high risk of clotting disorders
• People with a psychiatric illness or a history of not following medical instructions, if the study team considers this likely to prevent completion of the study
• People with uncontrolled thyroid disease, as determined by the study doctor
• People with a known allergy to Tofacitinib or any of its ingredients
• People who have taken part in another clinical trial or received an investigational treatment within the 6 months before screening (exceptions may apply for certain COVID-19 vaccines or treatments authorised under FDA emergency use — confirm with trial site)

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