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

NCT06936215 | Recruiting Phase 3 DMC

• 1 other identifier: 5011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Cutaneous Systemic Sclerosis

Keywords

Baricitinib in diffuse cutaneous systemic sclerosis

Outcome Measures

Primary Outcomes (1)

• change in mRSS score

  mRSS score is recorded at baseline and change in mRSS score is measured in subsequent follow ups at 4, 12 and 24 weeks

  24 weeks

Secondary Outcomes (2)

• Change in CDAI score

  24 weeks

• See the side effects of drugs

  24 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A participants will get tab. baricitinib 4 mg daily

Drug: tab baricitinib 4 mg daily

Group B

ACTIVE COMPARATOR

Group B participants will be given tab. Methotrexate 25 mg weekly with folic acid 5 mg weekly

Drug: tab methotrexate 25 mg weekly with folic acid 5 mg weekly

Interventions

tab baricitinib 4 mg daily DRUG

Group A participants will be given tab. Baricitinib 4 mg daily

Group A

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

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Diagnosis of diffuse cutaneous systemic sclerosis, as classified using the 2013 American College of Rheumatology
• \. Diffuse cutaneous systemic sclerosis as defined by 2001 LeRoy and Medsger 3. Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation) 4. mRSS score ≥ 10 at baseline

You may not qualify if:

• Subjects with any of the following characteristics/conditions will not be included in the study:
• Rheumatic disease other than systemic sclerosis. it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
• Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
• Major surgery (including joint surgery) within 8 weeks prior to screening visit
• Any infected ulcer prior to treatment
• Subjects with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .
• Oral corticosteroids \>10 mg/day of prednisone or equivalent.
• Mycophenolate mofetil \> 2 grams/day prior to baseline
• Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
• Current clinical, radiographic, or laboratory evidence of active TB.
• Positive for hepatitis B surface antigen at or within 30 days of screening.
• Positive for hepatitis C antigen at or within 30 days of screening.
• Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
• Pregnant or breastfeeding female subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 28 days after discontinuation of study drug.
• History of any malignancy in the last 5 years

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, Bangladesh

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

baricitinib; Methotrexate; Folic Acid

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr MD. Fahad Hossain, MBBS, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Md. Fahad Hossain, MBBS, MD

CONTACT

+8801811237435; fhosen14@gmail.com

Dr Md. Ariful Islam, MBBS, MD, FCPS

CONTACT

+8801730053723

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Open label randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 20, 2025
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-01

Locations

BA (1)