Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis

Phase 1

• Conditions: Patients with early active rheumatoid arthritis; MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-004179-38-SE
• Lead Sponsor: Västra Götalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-19
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. Diagnosis of seropositive (i.e., presence of RF and/or anti-CCP antibodies) RA according to the ACR/EULAR 2010 criteria within 24 months.
2. No previous treatment with DMARDs. History of prednisone use is allowed but should have been discontinued 2 weeks before baseline measurement.
3. Active disease with =2 painful and =2 swollen joints in 66/68 joints and CRP =2.0 mg/dl
4. Aged 18–80 years
5. Willing to undergo HRCT and PFTs

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. Current active inflammatory joint disease other than RA.
2. 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.
3. 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.
4. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
5. 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.
6. Pregnant or lactating women. Serum human chorionic gonadotropin will be measured prior to the first dosing of study drugs.
7. Positive tests for hepatitis B (HBsAg or HBV DNA) or hepatitis C serology.
8. History of herpes zoster infection during last 10 years.
9. History of venous thromboembolism or diverticulitis.
10. Positive tuberculosis history and/or positive Quantiferon test.
11. Hemoglobin <90 g/L.
12. Absolute neutrophil count (ANC) <1.5 ? 103/?L.
13. ASAT or ALAT >2.0 times the upper limit of normal.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified