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

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT06936215
Phase
PHASE3
Status
Recruiting
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Conditions

  • Diffuse Cutaneous Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tab baricitinib 4 mg daily — DRUG
    Group A participants will be given tab. Baricitinib 4 mg daily
  • tab methotrexate 25 mg weekly with folic acid 5 mg weekly — DRUG
    group A participants will be given tab. baricitinib 4 mg daily and group B participants will be given tab. methotrexate 25 mg weekly with folic acid 5 mg weekly

Study Details

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 a drug used in the treatment of skin tightening in SSc but has inconsistent response . Janus kinase (JAK) inhibitors are a class of drugs that may be used in skin involvement in dcSSc. Among them, baricitinib, a JAK 1/2 inhibitor, has shown some efficacy in dcSSc. The aim of this study is to assess the efficacy and safety of baricitinib on skin tightening in dcSSc patients. This open label randomized clinical trial will be conducted in department of rheumatology, BSMMU. Systemic sclerosis will be diagnosed by ACR/EULAR classification criteria 2013. Among them who have diffuse cutaneous involvement will be considered primary entry criteria for this study. Consecutive sampling method will be applied. Participants will be divided into two groups, group A and group B. Group A will be put on tab. baricitinib 4 mg daily and group B will be put on tab. methotrexate 25 mg weekly with folic acid 5 mg weekly. All participants will be assessed for mRSS, CDAI at baseline and laboratory tests like CBC, ESR, CRP, SGPT, serum creatinine, CXR P/A view etc. Follow up will be done at 4, 12, 24 weeks. Response to treatment will be assessed by modified Rodnan skin score. Primary endpoint of efficacy will be assessed by the end of 24th week. adverse effects will be assessed by history, physical examination and investigations. The data will be analyzed by SPSS version 25. results will be recorded using means and standard deviations. Result will be compared among groups with a 95% confidence interval and a p-value 0f\<0.05. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test for skewed distribution. Qualitative data in between groups will be analyzed by chi square test. Probabilities of association will be assessed by Spearman's rank correlation coefficient. P value of \< 0.05 will be regarded as statistically significant.

Key Dates

Start date
Jan 1, 2024
Status verified
Jan 2025
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Group A participants will get tab. baricitinib 4 mg daily
  • Active Comparator: Group B
    Group B participants will be given tab. Methotrexate 25 mg weekly with folic acid 5 mg weekly

Primary Outcome Measure

change in mRSS score [ Time Frame: 24 weeks ]

Central Contacts

  • Dr Md. Fahad Hossain, MBBS, MD
    +8801811237435
    [email protected]
  • Dr Md. Ariful Islam, MBBS, MD, FCPS
    +8801730053723

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