Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.

Last updated: April 26, 2023
Sponsor: National Institute of Respiratory Diseases, Mexico
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Musculoskeletal Diseases

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT05246293
C17-21
  • Ages > 18
  • All Genders

Study Summary

Nowadays, no single drug is approved to treat rheumatoid arthritis-related interstitial lung disease (RA-ILD). The medical management of this clinical condition is empirical and controversial. There is preliminary data that tofacitinib may have a beneficial effect in treating RA-ILD. Tofacitinib may have a double role in treating RA-ILD: treat RA disease activity and an anti-fibrotic possible impact. Moreover, tofacitinib may be used as monotherapy for the treatment of rheumatoid arthritis (RA) This is a phase IIa clinical trial to evaluate the safety and tolerability of tofacitinib in RA-ILD patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must fulfill ACR/EULAR 2010 RA classification criteria.
  2. Patients must have an interstitial lung disease confirmed by a high-resolutioncomputed tomography scan or a surgical lung biopsy. Nonspecific interstitialpneumonia, usual interstitial pneumonia, lymphocytic pneumonia, and organizedpneumonia, either by HRCT or surgical biopsy, will be included.
  3. Patients must be 18 years of age or older.
  4. There is no evidence of active, latent, or inadequately treated infection withMycobacterium tuberculosis (TB).
  5. Patients must discontinue using the non-permitted medications: leflunomide,azathioprine, cyclosporine, tacrolimus, cyclophosphamide, and any biologicdisease-modifying drug (bDMDARDs) such as anti-TNF therapy, rituximab, tocilizumab,etc. Patients must have a stable prednisone dose of ≤ 10 mg/ PO/day for at least threemonths.
  6. All patients must have stable doses of prednisone during the last three months offollow-up, and the prednisone dose must be ≤ 10 mg/day. Patients without a prednisonehistory in the previous three months may also be included in the protocol.

Exclusion

Exclusion Criteria:

  1. Seropositivity for the following infections: HIV, HBV, and HCV.
  2. Absolute neutrophil count ≤ 1,200/L
  3. Absolute platelet count ≤ 100,000 /L
  4. Severe renal damage with GFR < 30 ml/min based on CKD-EPI formula.
  5. AST or ALT greater than 1.5 times the upper limit of normal AST and ALT levels
  6. Severe hepatic, hematologic, gastrointestinal, cardiac, and neurological disease mayput the patient´s life at risk regardless of ILD severity.
  7. Severe active infections at baseline evaluation, such as pneumonia, urinary tractinfections, meningitis.

8 History of drug abuse or alcoholism. 9. History of any malignancy 10. Patients with anFVC < 40% of what is expected will be excluded from the study.

Study Design

Total Participants: 60
Study Start date:
August 08, 2022
Estimated Completion Date:
March 02, 2025

Study Description

This is a phase 2 open-label study designed to evaluate the safety and tolerability of tofacitinib in RA-ILD patients. Patients who met the inclusion criteria of the study protocol will receive tofacitinib 5 mg BID for 12 months.

Objectives

Primary objectives:

  1. To evaluate the safety and tolerability of tofacitinib 5 mg PO BID as monotherapy for managing RA-ILD in RA-ILD patients.

  2. To evaluate the pulmonary function of patients treated with tofacitinib PO BID as monotherapy to manage RA-ILD in RA-ILD patients, at baseline, at three months of follow-up, at six months of follow-up, and one year of follow-up.

  3. To estimate the efficacy of tofacitinib 5 mg PO BID as monotherapy for the management of RA-ILD, in RA-ILD patients, at three months of follow-up, at six months of follow-up, and at one year of follow-up, according to the ACR 20, 50, 70 response criteria, and the following disease activity scores index: DAS 28, CDAI and SDAI.

All the included patients will receive Tofacitinib in doses of 5 mg BID until the end of the protocol.

Connect with a study center

  • Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas

    Mexico City, Tlalpan 14080
    Mexico

    Active - Recruiting

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