Rheumatoid ArthritisPhase 2RAILDToNCT05246293
Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.
A Phase 2 study testing Tofacitinib in people with Rheumatoid Arthritis and Interstitial Lung Disease, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Interstitial Lung Disease
- What is being tested?
- Tofacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 8 Aug 2022to 2 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must fulfill ACR/EULAR 2010 RA classification criteria.
- Patients must have an interstitial lung disease confirmed by a high-resolution computed tomography scan or a surgical lung biopsy. Nonspecific interstitial pneumonia, usual interstitial pneumonia, lymphocytic pneumonia, and organized pneumonia, either by HRCT or surgical biopsy, will be included.
- Patients must be 18 years of age or older.
- There is no evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
- Patients must discontinue using the non-permitted medications: leflunomide, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, and any biologic disease-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 three months.
- All patients must have stable doses of prednisone during the last three months of follow-up, and the prednisone dose must be ≤ 10 mg/day. Patients without a prednisone history in the previous three months may also be included in the protocol.
Who cannot join
- Seropositivity for the following infections: HIV, HBV, and HCV.
- Absolute neutrophil count ≤ 1,200/L
- Absolute platelet count ≤ 100,000 /L
- Severe renal damage with GFR < 30 ml/min based on CKD-EPI formula.
- AST or ALT greater than 1.5 times the upper limit of normal AST and ALT levels
- Severe hepatic, hematologic, gastrointestinal, cardiac, and neurological disease may put the patient´s life at risk regardless of ILD severity.
Show all 9Show fewer
- Severe active infections at baseline evaluation, such as pneumonia, urinary tract infections, meningitis.
- 8 History of drug abuse or alcoholism. 9. History of any malignancy 10. Patients with an FVC < 40% of what is expected will be excluded from the study.
- -
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas
Mexico City, Tlalpan, 14080
Jorge Rojas-Serrano, MD, PhD, + 52 5554871700 ext. 5276, jrojas@iner.gob.mx
Andrea Estrada-Garrido, MD, +52 5554871700 ext. 5276, estradagara@yahoo.com.mx
About this study
Official title: Safety and Tolerability of Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease (RAILDTo Trial).
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.
Read the detailed 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:
- To evaluate the safety and tolerability of tofacitinib 5 mg PO BID as monotherapy for managing RA-ILD in RA-ILD patients.
- 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.
- 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.
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Being tested
- Tofacitinib
- Keywords
- Rheumatoid Arthritis, Interstitial Lung Disease, Usual interstitial pneumonia, Tofacitinib, Rheumatoid Arthritis-related interstitial lung disease
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Tofacitinib in doses of 5 mg BID, in RA-ILD patients at stable doses of prednisone ≤ 10 mg/day during the last three months.
Patients who met the inclusion criteria of the study protocol will received tofacitinib 5 mg BID for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib Arm | Experimental | Tofacitinib in doses of 5 mg BID, in RA-ILD patients at stable doses of prednisone ≤ 10 mg/day during the last three months. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Adverse event: Any untoward medical occurrence in a subject being included in the trial, in which the event may not necessarily have a causal relationship with the treatment. Examples of adverse events are as follows: abnormal test findings, clinically significant symptoms and signs, hypersensitivity reactions, and progression or worsening of RA or RA-ILD.
Measured: 52 weeks
Secondary outcomes (5)
Forced Vital Capacity (liters)
Forced vital capacity (FVC) on spirometry, the data will be presented as percentages of predicted values, according to sex, age, height, and weight.
Measured: 52 weeks
Carbon monoxide diffusing capacity (DLCO) (mil/min/mmHg)
The data will be presented as percentages of predicted values, according to sex, age, height, and weight.
Measured: 52 weeks
6 minutes walk test
walked metters in 6 minutes
Measured: 52 weeks
Rheumatoid arthritis disease activity according to the simplified disease activity (SDAI) index.
The SDAI index consists of the algebraic sum of the following items: tender joint count, swollen joint count, c-reactive protein, rheumatoid arthritis activity according to the patient, disease activity according to the attending physician.
Measured: 52 weeks
Rheumatoid arthritis disease activity according to the Disease Activity Score Index (DAS28)
The DAS28 score is calculated with the tender joint count, swollen joint count, eritrosedimentation rate, patients' global health assesment aacording with the following formula DAS28 = ( 0.56 * sqr(TJC)) + (0.28 * sqr(SJC)) + ( 0.7 * ln(VSG)) + (0.014 * GH)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start8 Aug 2022
- Primary completion2 Mar 2024 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jorge Rojas-Serrano, MD, PhD, Principal investigator, Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246293
- Sponsor's protocol ID
- C17-21
- Acronym
- RAILDTo
- Status last verified
- Apr 2022
- First submitted
- 17 Jan 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data, including data dictionaries and analytic code, after presenting the results of the study in a congress or the final publication of the clinical trial. The data will be shared only if a formal research proposal and our local IRB approves this.
Publications
Vacchi C, Manfredi A, Cassone G, Cerri S, Della Casa G, Andrisani D, Salvarani C, Sebastiani M. Tofacitinib for the Treatment of Severe Interstitial Lung Disease Related to Rheumatoid Arthritis. Case Rep Med. 2021 Apr 22;2021:6652845. doi: 10.1155/2021/6652845. eCollection 2021.
PubMed 33976699Citera G, Mysler E, Madariaga H, Cardiel MH, Castaneda O, Fischer A, Richette P, Chartrand S, Park JK, Strengholt S, Rivas JL, Thorat AV, Girard T, Kwok K, Wang L, Ponce de Leon D. Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients: Post Hoc Analysis From 21 Clinical Trials. J Clin Rheumatol. 2021 Dec 1;27(8):e482-e490. doi: 10.1097/RHU.0000000000001552.
PubMed 32826657Harigai M. Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019 Feb 1;58(Suppl 1):i34-i42. doi: 10.1093/rheumatology/key287.
PubMed 30806708Rojas-Serrano J, Ramos-Martinez E, Mejia M, Castillo-Lopez MF, Lira-Boussart V, Rivero-Gallegos D, Garcia-Carmona S, Perez-Rubio G, Falfan-Valencia R. Tofacitinib Reduces KL-6 Levels in Patients With Rheumatoid Arthritis-Associated Interstitial Lung Disease. Results Of A Phase II Investigator-Initiated Study. Respir Med. 2026 Sep 10:109150. doi: 10.1016/j.rmed.2026.109150. Online ahead of print.
PubMed 42722091
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease (RAILDTo Trial).
- ClinicalTrials.gov ID
- NCT05246293
- Acronym / sponsor ID
- RAILDTo / C17-21
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Keywords
- Rheumatoid Arthritis, Interstitial Lung Disease, Usual interstitial pneumonia, Tofacitinib, Rheumatoid Arthritis-related interstitial lung disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 2 Mar 2024 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- To evaluate the safety and tolerability of tofacitinib 5 mg PO BID as monotherapy for managing RA-ILD in RA-ILD patients.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib Arm | Experimental | Drug: TofacitinibTofacitinib in doses of 5 mg BID, in RA-ILD patients at stable doses of prednisone ≤ 10 mg/day during the last three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must fulfill ACR/EULAR 2010 RA classification criteria.
- Patients must have an interstitial lung disease confirmed by a high-resolution computed tomography scan or a surgical lung biopsy. Nonspecific interstitial pneumonia, usual interstitial pneumonia, lymphocytic pneumonia, and organized pneumonia, either by HRCT or surgical biopsy, will be included.
- Patients must be 18 years of age or older.
- There is no evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
- Patients must discontinue using the non-permitted medications: leflunomide, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, and any biologic disease-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 three months.
Key exclusion criteria (9 listed)
- Seropositivity for the following infections: HIV, HBV, and HCV.
- Absolute neutrophil count ≤ 1,200/L
- Absolute platelet count ≤ 100,000 /L
- Severe renal damage with GFR < 30 ml/min based on CKD-EPI formula.
- AST or ALT greater than 1.5 times the upper limit of normal AST and ALT levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibTofacitinib in doses of 5 mg BID, in RA-ILD patients at stable doses of prednisone ≤ 10 mg/day during the last three months. Patients who met the inclusion criteria of the study protocol will received tofacitinib 5 mg BID for 12 months | Drug | Tofacitinib Arm |
Primary outcome
Incidence and severity of adverse events
Time frame: 52 weeks
Adverse event: Any untoward medical occurrence in a subject being included in the trial, in which the event may not necessarily have a causal relationship with the treatment. Examples of adverse events are as follows: abnormal test findings, clinically significant symptoms and signs, hypersensitivity reactions, and progression or worsening of RA or RA-ILD.
5 secondary outcomes
Forced Vital Capacity (liters)
Time frame: 52 weeks
Carbon monoxide diffusing capacity (DLCO) (mil/min/mmHg)
Time frame: 52 weeks
6 minutes walk test
Time frame: 52 weeks
Rheumatoid arthritis disease activity according to the simplified disease activity (SDAI) index.
Time frame: 52 weeks
Rheumatoid arthritis disease activity according to the Disease Activity Score Index (DAS28)
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 33976699Vacchi C, Manfredi A, Cassone G, Cerri S, Della Casa G, Andrisani D, Salvarani C, Sebastiani M. Tofacitinib for the Treatment of Severe Interstitial Lung Disease Related to Rheumatoid Arthritis. Case Rep Med. 2021 Apr 22;2021:6652845. doi: 10.1155/2021/6652845. eCollection 2021.
- Background: PubMed 32826657Citera G, Mysler E, Madariaga H, Cardiel MH, Castaneda O, Fischer A, Richette P, Chartrand S, Park JK, Strengholt S, Rivas JL, Thorat AV, Girard T, Kwok K, Wang L, Ponce de Leon D. Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients: Post Hoc Analysis From 21 Clinical Trials. J Clin Rheumatol. 2021 Dec 1;27(8):e482-e490. doi: 10.1097/RHU.0000000000001552.
- Background: PubMed 30806708Harigai M. Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019 Feb 1;58(Suppl 1):i34-i42. doi: 10.1093/rheumatology/key287.
- Derived from this study: PubMed 42722091Rojas-Serrano J, Ramos-Martinez E, Mejia M, Castillo-Lopez MF, Lira-Boussart V, Rivero-Gallegos D, Garcia-Carmona S, Perez-Rubio G, Falfan-Valencia R. Tofacitinib Reduces KL-6 Levels in Patients With Rheumatoid Arthritis-Associated Interstitial Lung Disease. Results Of A Phase II Investigator-Initiated Study. Respir Med. 2026 Sep 10:109150. doi: 10.1016/j.rmed.2026.109150. Online ahead of print.
- Individual participant dataSharing planned: Yes. We will share data, including data dictionaries and analytic code, after presenting the results of the study in a congress or the final publication of the clinical trial. The data will be shared only if a formal research proposal and our local IRB approves this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Rojas-Serrano, MD, PhD principal investigator
Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tofacitinib in people with Rheumatoid Arthritis and Interstitial Lung Disease, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Rojas-Serrano, MD, PhD (+ 52 5554871700 ext. 5276, jrojas@iner.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246293, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.