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.
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. Ariful Islam, MBBS, MD, FCPS
+8801730053723
CONTACT