New hope for scleroderma: arthritis drug tofacitinib tested against skin thickening
NCT ID NCT07472166
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether tofacitinib (a JAK inhibitor drug) works better than methotrexate (a standard treatment) at reducing skin thickening in people with a severe form of scleroderma called diffuse cutaneous systemic sclerosis. Thirty-four adults with early-stage disease took either tofacitinib twice daily or methotrexate once weekly for 24 weeks. Researchers measured changes in skin hardness using a standard scoring system, along with joint symptoms and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tofacitinib (a JAK inhibitor drug) and Methotrexate (a standard immune-suppressing drug)
- What this could lead to
- If tofacitinib works better than methotrexate, it could offer a new treatment option to reduce skin hardening and improve quality of life in people with this rare autoimmune disease.
- What could go wrong
- This is a small, single-center study with only 34 participants, so results may not apply to everyone. Both drugs have side effects like infection risk, and the trial is short (24 weeks), so long-term benefits or risks are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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34 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka, 1000, Bangladesh
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new pill ease the hardening skin of systemic sclerosis?
- Are women with autoimmune diseases getting the gynecological care they need?
- Could blocking TL1A stop skin scarring in scleroderma? early lab study hints at possibility
- New shot aims to tame rare autoimmune disease