Scleroderma, SystemicPhase 4NCT07472166

Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate

A Phase 4 study testing Tofacitinib and Methotrexate in people with Scleroderma, Systemic, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to evaluate the efficacy of Tofacitinib compared to Methotrexate (MTX) in reducing skin thickening in patients with diffuse cutaneous systemic sclerosis (dcSSc). Systemic sclerosis is a chronic autoimmune disease characterized by skin fibrosis and internal organ involvement. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Scleroderma, Systemic
What is being tested?: Tofacitinib and Methotrexate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteBangladesh
Study dates: 21 Dec 2024to 30 Aug 2025
Phase: Phase 4
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

1. Diagnosed with systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria 2. Classified as having diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy and Medsger 3. Disease duration of ≤ 36 months, calculated from the onset of the first non-Raynaud's phenomenon manifestation.
4. Modified Rodnan Skin Score (mRSS) between 10 and 45 at the time of screening.
5. Concurrent use of calcium channel blockers and phosphodiesterase-5 inhibitors for the treatment of Raynaud's phenomenon or digital ulcers was permitted.
6. Subjects were aged 18 years and older

Who cannot join

1. Presence of a rheumatic disease other than systemic sclerosis, except for fibromyalgia or scleroderma-associated myopathy.
2. Evidence of any active infection, including active tuberculosis 3. Abnormal laboratory values at screening, including:
Hemoglobin <9 g/dL
White blood cell count <3.0 × 10⁹/L
Absolute neutrophil count <1.2 × 10⁹/L
Platelet count <100 × 10⁹/L

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Absolute lymphocyte count <0.75 × 10⁹/L
ALT or AST >3× the upper limit of normal (ULN)
Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²
4. Pulmonary function showing forced vital capacity (FVC) ≤ 50% predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% predicted.
5. History of major surgery (including joint surgery) within 8 weeks prior to the screening visit.
6. Use of oral corticosteroids 7. Diagnosis of latent TB at or within 30 days of screening. 8. Positive hepatitis B surface antigen or anti HCV test at or within 30 days of screening.
9. Pregnant or breastfeeding women, females of childbearing potential who were unwilling or unable to use highly effective contraception during the study 10. History or evidence of malignancy 11. Receipt of a live or attenuated vaccine within 6 weeks prior to baseline

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka, 1000

Other trials in Bangladesh

About this study

Tofacitinib, a Janus kinase (JAK) inhibitor, has shown potential benefit in reducing inflammation and fibrosis in autoimmune diseases. This randomized controlled study will compare the change in Modified Rodnan Skin Score (mRSS), Clinical Disease Activity Index (CDAI), and 12-Item Short Form Survey (SF-12) between the Tofacitinib and Methotrexate groups over the study period.

The study will also monitor adverse events and laboratory parameters to assess drug safety and tolerability.

Conditions: Scleroderma, Systemic
Being tested: Tofacitinib, Methotrexate
Keywords: Methotrexate, Skin thickening, mRSS, Autoimmune disease, Tofacitinib
Medical subject headings: Scleroderma, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TofacitinibDrug
Tofacitinib: 5mg orally twice daily for 24 weeks
MethotrexateDrug
25mg orally once weekly for 24 weeks

Study groups in NCT07472166
Study group	Role	What they receive
Tofacitinib group	Experimental	Not described Receives: Drug: Tofacitinib
Methotrexate group	Active comparator	Not described Receives: Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Modified Rodnan Skin Score (mRSS) from baseline to week 24 Scale range: 0 (no skin thickening) to 51 (most severe skin thickening) Higher score indicate worse skin thickening (worse outcome)
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 202430 Aug 2025

First posted16 Mar 2026
Study start21 Dec 2024
Primary completion30 Aug 2025
Study completion30 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Scleroderma, SystemicStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07472166
Sponsor's protocol ID: 5230
Status last verified: Mar 2025
First submitted: 9 Mar 2026
Last updated: 16 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

All Scleroderma, Systemic trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
ClinicalTrials.gov ID: NCT07472166
Acronym / sponsor ID: 5230
Conditions: Scleroderma, Systemic
Keywords: Methotrexate, Skin thickening, mRSS, Autoimmune disease, Tofacitinib
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
Study start: 21 Dec 2024 (actual)
Primary completion: 30 Aug 2025 (actual)
Study completion: 30 Aug 2025 (actual)
First posted: 16 Mar 2026 (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.

The study will also monitor adverse events and laboratory parameters to assess drug safety and tolerability.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tofacitinib group	Experimental	Drug: Tofacitinib
Methotrexate group	Active comparator	Drug: Methotrexate

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1. Diagnosed with systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria 2. Classified as having diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy and Medsger 3. Disease duration of ≤ 36 months, calculated from the onset of the first non-Raynaud's phenomenon manifestation.
4. Modified Rodnan Skin Score (mRSS) between 10 and 45 at the time of screening.
5. Concurrent use of calcium channel blockers and phosphodiesterase-5 inhibitors for the treatment of Raynaud's phenomenon or digital ulcers was permitted.
6. Subjects were aged 18 years and older

Key exclusion criteria (13 listed)

1. Presence of a rheumatic disease other than systemic sclerosis, except for fibromyalgia or scleroderma-associated myopathy.
2. Evidence of any active infection, including active tuberculosis 3. Abnormal laboratory values at screening, including:
4. Pulmonary function showing forced vital capacity (FVC) ≤ 50% predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% predicted.
5. History of major surgery (including joint surgery) within 8 weeks prior to the screening visit.
6. Use of oral corticosteroids 7. Diagnosis of latent TB at or within 30 days of screening. 8. Positive hepatitis B surface antigen or anti HCV test at or within 30 days of screening.

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: 5mg orally twice daily for 24 weeks	Drug	Tofacitinib group
Methotrexate25mg orally once weekly for 24 weeks	Drug	Methotrexate group

Primary outcome

Change in Modified Rodnan Skin Score (mRSS) from baseline to week 24 Scale range: 0 (no skin thickening) to 51 (most severe skin thickening) Higher score indicate worse skin thickening (worse outcome)
Time frame: Baseline and Week 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
Individual participant dataSharing planned: No

Related trials for Scleroderma, Systemic

Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

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.

Md. Abu Shahin, FCPS, MD study chair

Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tofacitinib and Methotrexate in people with Scleroderma, Systemic, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

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 4 inclusion and 13 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: finished, as of the sponsor's last update on 16 Mar 2026. 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 Bangladesh. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Rodnan Skin Score (mRSS) from baseline to week 24 Scale range: 0 (no skin thickening) to 51 (most severe skin thickening) Higher score indicate worse skin thickening (worse outcome) (time frame: Baseline and Week 24). 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 NCT07472166.

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 16 Mar 2026.