Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate

Recruiting Phase 3 Interventional Study
Diffuse Cutaneous Systemic Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Other
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About This Trial
Systemic sclerosis (SSc) is a systemic autoimmune disease. It causes progressive skin tightening, pulmonary fibrosis, organ damage and many other physical dysfunctions. It is divided into two types, limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSCc). Skin involvement in systemic sclerosis is assessed by modified Rodnan skin score (mRSS). Methotrexate is …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\. Diagnosis of diffuse cutaneous systemic sclerosis, as classified using the 2013 American College of Rheumatology 2\. Diffuse cutaneous systemic sclerosis as defined by 2001 LeRoy and Medsger 3. Disease duration ≤ 60 months (defined as time from the first non-Raynaud phe…
Contacts

Dr Md. Fahad Hossain, MBBS, MD

+8801811237435

fhosen14@gmail.com

CONTACT

Dr Md. Ariful Islam, MBBS, MD, FCPS

+8801730053723

CONTACT