Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative… (NCT07472166) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Bangladesh34 participantsStarted 2024-12-21
Plain-language 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. Despite existing treatments, many patients continue to experience progressive skin and joint symptoms.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. Diagno…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Baseline and Week 24
Trial details
NCT IDNCT07472166
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh