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

NCT ID: NCT06936215

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group A participants will get tab. baricitinib 4 mg daily

Group Type: EXPERIMENTAL

tab baricitinib 4 mg daily

Intervention Type: DRUG

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

Group B

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

Group Type: ACTIVE_COMPARATOR

tab methotrexate 25 mg weekly with folic acid 5 mg weekly

Intervention Type: 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

Interventions

tab baricitinib 4 mg daily

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

Intervention Type: DRUG

tab methotrexate 25 mg weekly with folic acid 5 mg weekly

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

Intervention Type: DRUG

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 phenomenon manifestation) 4. mRSS score ≥ 10 at baseline

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:

1. Rheumatic disease other than systemic sclerosis. it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy

2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit

3. Major surgery (including joint surgery) within 8 weeks prior to screening visit

4. Any infected ulcer prior to treatment

5. Subjects with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .

6. Oral corticosteroids >10 mg/day of prednisone or equivalent.

7. Mycophenolate mofetil > 2 grams/day prior to baseline

8. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted

9. Current clinical, radiographic, or laboratory evidence of active TB.

10. Positive for hepatitis B surface antigen at or within 30 days of screening.

11. Positive for hepatitis C antigen at or within 30 days of screening.

12. Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.

13. 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.

14. History of any malignancy in the last 5 years

15. History of SSc Renal Crisis within the 6 months prior to baseline.

16. Patients with a history of anaphylaxis to Baricitinib or methotrexate

17. Any of the following lab results at screening:

• Hemoglobin <8 g/dl
• White Blood Cell count <3.0 x 109/L;
• Absolute Neutrophil count <1.2 x 109/L;
• Platelet count <100 x 109/L;
• Absolute Lymphocyte count <0.75 x 109/L.
• ALT > 3 × the upper limit of normal (ULN) of normal at screening
• Estimated glomerular filtration rate [GFR] <60mL/min/1.73 m2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Fahad Hossain

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr MD. Fahad Hossain, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

BSMMU

Dhaka, , Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Dr Md. Fahad Hossain, MBBS, MD

Role: CONTACT

fhosen14@gmail.com

+8801811237435

Dr Md. Ariful Islam, MBBS, MD, FCPS

Role: CONTACT

+8801730053723

Facility Contacts

Fahad Hossain, MBBS, MD

Role: primary

fhosen14@gmail.com

+8801811237435

Dr Ariful Islam, MBBS, FCPS, MD

Role: backup

ariful_islam7400@yahoo.com

+8801730053723

Other Identifiers

5011

Identifier Type: -

Identifier Source: org_study_id