NCT05246293 (RAILDTo) is a Phase 2 clinical trial of Tofacitinib in Rheumatoid Arthritis, sponsored by National Institute of Respiratory Diseases, Mexico.

Who is sponsoring NCT05246293?

NCT05246293 is sponsored by National Institute of Respiratory Diseases, Mexico.

What drugs are being tested in NCT05246293?

Interventions in NCT05246293: Tofacitinib.

What condition does NCT05246293 study?

NCT05246293 studies Rheumatoid Arthritis, Interstitial Lung Disease.

Is NCT05246293 still recruiting?

NCT05246293 is currently status unknown. Last updated 27 April 2023.

Last reviewed 2023-04-27 · How we verify

NCT05246293: RAILDTo

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 2 Last updated 27 April 2023

What this trial tests

Phase 2 trial testing Tofacitinib in Rheumatoid Arthritis in 60 participants. Status unknown.

Timeline

8 August 2022

Primary endpoint
2 March 2024

2 March 2025

Quick facts

Lead sponsor	National Institute of Respiratory Diseases, Mexico
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	8 August 2022
Primary completion	2 March 2024
Estimated completion	2 March 2025
Sites	1 location across Mexico

Drugs / interventions tested

Tofacitinib (tofacitinib) — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Interstitial Lung Disease — all drugs for Interstitial Lung Disease →

Sponsor

National Institute of Respiratory Diseases, Mexico

Who can join

18 and older, any sex, with Rheumatoid Arthritis or Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Unmet needs and perspectives in rheumatoid arthritis-associated interstitial lung disease: A critical review.
Stainer A, Tonutti A, De Santis M, Amati F, et al · · 2023 · cited 22× · PMID 37007765 · DOI 10.3389/fmed.2023.1129939
Serum proteomic profiling of rheumatoid arthritis-interstitial lung disease with a comparison to idiopathic pulmonary fibrosis.
Wu X, Jeong Y, Poli de Frías S, Easthausen I, et al · · 2022 · cited 17× · PMID 35907639 · DOI 10.1136/thorax-2021-217822
The Role of Macrophages in Connective Tissue Disease-Associated Interstitial Lung Disease: Focusing on Molecular Mechanisms and Potential Treatment Strategies.
Tseng CC, Sung YW, Chen KY, Wang PY, et al · · 2023 · cited 15× · PMID 37569370 · DOI 10.3390/ijms241511995
CD206<sup>+</sup> macrophages are relevant non-invasive imaging biomarkers and therapeutic targets in experimental lung fibrosis.
Pommerolle L, Beltramo G, Biziorek L, Truchi M, et al · · 2024 · cited 13× · PMID 39033028 · DOI 10.1136/thorax-2023-221168
Collagen-targeted PET imaging for progressive experimental lung fibrosis quantification and monitoring of efficacy of anti-fibrotic therapies.
Dias AMM, Burgy O, Moreau M, Goncalves V, et al · · 2025 · cited 6× · PMID 39990206 · DOI 10.7150/thno.106367
Targeting rheumatoid arthritis: a molecular perspective on biologic therapies and clinical progress.
Jain A, Bishnoi M, Prajapati SK, Acharya S, et al · · 2025 · cited 3× · PMID 40707975 · DOI 10.1186/s13036-025-00534-8
Advanced interstitial lung disease: Evidence-based management and clinical approach.
Kattih Z, Greenstein Z, Makkar P, Gupta R. · · 2025 · cited 1× · PMID 40699491 · DOI 10.36141/svdld.v42i2.16206
Clinical Insights and Therapeutic Strategies for the Treatment of Interstitial Lung Disease in Patients with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: Current Trends and Future Directions.
Fijolek J, Sniady A. · · 2025 · cited 1× · PMID 40649005 · DOI 10.3390/jcm14134631

Verify or expand the search:

Other trials of Tofacitinib

Trials testing the same drug.

NCT07530367 — A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Pati · Phase 3 · not yet recruiting
NCT07406204 — Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA) · Phase 4 · not yet recruiting
NCT07343635 — The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined · NA · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT07297069 — Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial · Phase 2 · not yet recruiting

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other National Institute of Respiratory Diseases, Mexico trials

Trials by the same sponsor.

NCT06511284 — Nutritional Therapy in Patients With Post-extubation Dysphagia · NA · recruiting
NCT06254001 — Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects · Phase 4 · recruiting
NCT06571942 — Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure · Phase 4 · recruiting
NCT05685641 — Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City · NA · unknown
NCT05243316 — Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05246293 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Respiratory Diseases, Mexico
Last refreshed: 27 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05246293.

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