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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004179-38-SE

Enrollment

145

Registered

2019-11-19

Start date

2020-01-10

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with early active rheumatoid arthritis MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870

Interventions

Trade Name: Xeljanz Pharmaceutical Form: Tablet Trade Name: Metotrexat Orion Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 2.0 times the upper limit of normal.

Design outcomes

Primary

Measure	Time frame
Main Objective: Effect of tofacitinib compared to that of methotrexate on interstitial pulmonary abnormalities at 24 weeks. ;Secondary Objective: Effects of tofacitinib vs methotrexate on; pulmonary abnormalities by HRCT total score at 48 weeks and by pattern category at 24 and 48 weeks, pulmonary function by spirometry and diffusion capacity at 24 and 48 weeks, RA disease activity (joint counts and ESR/CRP) at 12, 24 and 48 weeks and remission at 24 and 48 weeks, radiographic progression extremities at 24 and 48 weeks, patient reported outcomes on disease activity and pulmonary symptoms at 24 and 48 weeks, safety and tolerability.;Primary end point(s): Effects of tofacitinib compared to effects of methotrexate on mean change in total interstitial disease score of pulmonary abnormalities by HRCT at 24 weeks compared to baseline. The score is a total sum of the extent (percentage ration of pattern area to total lung area) of abnormalities by category (reticulations, ground-glass, honey-combing, consolidations and emphysema) at six different levels of the lungs. It is a quantitative score but the pattern definition and borders are determined by two independent bilded assessors.;Timepoint(s) of evaluation of this end point: At 24 weeks.	—

Measure

Time frame

Main Objective: Effect of tofacitinib compared to that of methotrexate on interstitial pulmonary abnormalities at 24 weeks. ;Secondary Objective: Effects of tofacitinib vs methotrexate on; pulmonary abnormalities by HRCT total score at 48 weeks and by pattern category at 24 and 48 weeks, pulmonary function by spirometry and diffusion capacity at 24 and 48 weeks, RA disease activity (joint counts and ESR/CRP) at 12, 24 and 48 weeks and remission at 24 and 48 weeks, radiographic progression extremities at 24 and 48 weeks, patient reported outcomes on disease activity and pulmonary symptoms at 24 and 48 weeks, safety and tolerability.;Primary end point(s): Effects of tofacitinib compared to effects of methotrexate on mean change in total interstitial disease score of pulmonary abnormalities by HRCT at 24 weeks compared to baseline. The score is a total sum of the extent (percentage ration of pattern area to total lung area) of abnormalities by category (reticulations, ground-glass, honey-combing, consolidations and emphysema) at six different levels of the lungs. It is a quantitative score but the pattern definition and borders are determined by two independent bilded assessors.;Timepoint(s) of evaluation of this end point: At 24 weeks.

—

Secondary

Measure	Time frame
Secondary end point(s): Effects of tofacitinib compared to effects of methotrexate on: • Pulmonary abnormalities on HRCT at 48 weeks (total interstitial disease score) and by category at 24 and 48* weeks • Pulmonary function at 24 and 48* weeks • Patient-reported outcomes on disease symptoms at 24 and 48* weeks • RA disease activity at 12, 24 and 48* weeks • RA remission at 24 and 48* weeks • Erosivity at 24 and 48* weeks • Safety and tolerability every 2-4 weeks;Timepoint(s) of evaluation of this end point: Effects of tofacitinib compared to effects of methotrexate on: • Pulmonary abnormalities on HRCT by category at 24 and 48* weeks • Pulmonary function at 24 and 48* weeks • Patient-reported outcomes on disease symptoms at 24 and 48* weeks • RA disease activity at 12, 24 and 48* weeks • RA remission at 24 and 48* weeks • Erosivity at 24 and 48* weeks • Safety and tolerability every 2-4 weeks	—

Measure

Time frame

Secondary end point(s): Effects of tofacitinib compared to effects of methotrexate on: • Pulmonary abnormalities on HRCT at 48 weeks (total interstitial disease score) and by category at 24 and 48* weeks • Pulmonary function at 24 and 48* weeks • Patient-reported outcomes on disease symptoms at 24 and 48* weeks • RA disease activity at 12, 24 and 48* weeks • RA remission at 24 and 48* weeks • Erosivity at 24 and 48* weeks • Safety and tolerability every 2-4 weeks;Timepoint(s) of evaluation of this end point: Effects of tofacitinib compared to effects of methotrexate on: • Pulmonary abnormalities on HRCT by category at 24 and 48* weeks • Pulmonary function at 24 and 48* weeks • Patient-reported outcomes on disease symptoms at 24 and 48* weeks • RA disease activity at 12, 24 and 48* weeks • RA remission at 24 and 48* weeks • Erosivity at 24 and 48* weeks • Safety and tolerability every 2-4 weeks

—

Countries

Sweden

Contacts

Public ContactCRRC-SU monitored mailbox

Västra Götalandsregionen

koordinator.reuma@vgregion.se00460700 20 65 77

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026