Status:
TERMINATED
Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Göteborg University
Conditions:
Rheumatoid Arthritis
Interstitial Lung Disease Due to Systemic Disease (Disorder)
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Pulmonary abnormalities are present in up to 60% of patients with early rheumatoid arthritis (RA), and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indi...
Detailed Description
Study objectives: Primary objective: Effects of tofacitinib compared to that of methotrexate on interstitial pulmonary abnormalities at 24 weeks. Secondary objectives: Effects of tofacitinib compare...
Eligibility Criteria
Inclusion
- Diagnosis of seropositive (i.e., presence of RF and/or anti-CCP antibodies) rheumatoid arthritis (RA) according to the ACR/EULAR 2010 criteria within 24 months.
- No previous treatment with disease modifying anti-rheumatic drugs (DMARDs). History of prednisone use is allowed but should have been discontinued 2 weeks before baseline measurement.
- Active disease with ≥2 painful and ≥2 swollen joints in 66/68 joints and CRP ≥2.0 mg/L
- Aged 18-80 years
- The subject has given written consent to participate in the study.
Exclusion
- Current active inflammatory joint disease other than RA.
- Significant and/or uncontrolled cardiac, pulmonary disease, nervous system, renal, hepatic, endocrine or gastrointestinal disorders or severe RA which in the investigator's opinion would preclude patient participation.
- Malignancy within the past 5 years, except for successfully treated cervical carcinoma in situ, basal cell and squamous cell carcinoma of the skin, with no evidence of recurrence or metastatic disease for at least 3 years.
- Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
- Pregnant or lactating women.
- For subjects in part II the following exclusion criteria also apply:
- Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) for 28 days prior and 3 months after end of study.
- Active infection (excluding fungal infections of nail beds) requiring i.v. anti-infectives within 4 weeks, or oral anti-infectives within 2 weeks prior to baseline.
- Positive tests for hepatitis B (HBsAg or HBV DNA),hepatitis C serology or SARS-CoV2
- History of herpes zoster infection during last 10 years.
- History or risk of venous thromboembolism or diverticulitis.
- Positive tuberculosis history and/or positive Quantiferon test.
- Hemoglobin \<90 g/L.
- Absolute neutrophil count \< 1500 cells/uL.
- ASAT or ALAT \>2.0 times the upper limit of normal.
- High or very high risk (≥ 5%) of cardiovascular death within 10 years by SCOREx1,5.
- Multiple incidental solid/subsolid lung nodules of size ≥6 mm, single incidental solid lung nodules ≥8 mm.
Key Trial Info
Start Date :
November 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04311567
Start Date
November 7 2020
End Date
March 26 2024
Last Update
May 23 2024
Active Locations (3)
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1
Skåne University Hospital, Department of Rheumatology
Lund, Skåne County, Sweden, 20502
2
Clinical Rheumatology Research Center, The Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 41345
3
Karolinska University Hospital, Department of Rheumatology
Stockholm, Sweden, 17176