Effectiveness of Tofacitinib in Systemic Sclerosis

Phase 2

Recruiting

• Conditions: Efficacy of Tofacitinib in the Systemic Sclerosis
• Interventions: Drug: Tofacitinib

• Registration Number: NCT06044844
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

The goal of this clinical trial is to compare efficacy of tofacitinib with cyclophosphamide in skin thickening in early diffuse cutaneous systemic sclerosis .

Detailed Description

compare tofacitinib 5mg twice daily with cyclophosphamide 500mg/m2/month in early diffuse cutaneous systemic sclerosis

Study Timeline

• Study First Submitted: 2023-06-07
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Study Start: 2023-11
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

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

1. Any infection at screening .

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

3. Pulmonary disease with FVC ≤ 35% of predicted.

4. Subjects at risk for tuberculosis (TB).Specifically excluded from this study with a history of active TB within the last 3 years and current clinical, radiographic, or laboratory evidence of active TB.j

5. Latent TB at or within 30 days of screening.

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

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

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

9. History of diverticulitis or chronic, ulcerative lower GI disease such as Crohns disease, ulcerative colitis, or other symptomatic, lower GI conditions that might predispose a patient to perforations.

10. 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.

11. History of any malignancy in the last 5 years with the exception of adequately treated or excised basal cell or squamous cell or cervical cancer in situ.

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

13. History of live/attenuated vaccine ≤ 6 weeks prior to baseline

14. Any of the following lab results at screening:

    • Hemoglobin <9 g/dL or Hematocrit <30%
    • 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 or AST > 3 × the upper limit of normal (ULN) of normal at screening or any
    • Total bilirubin > ULN at Screening.
    • Estimated glomerular filtration rate [GFR] <40mL/min/1.73 m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis	Tofacitinib	tab tofacitinib 5mg twice daily will be given by oral route for 6month
efficacy of Cyclophosphamide in early diffuse cutaneous systemic sclerosis	Tofacitinib	injection cyclophosphamide 500mg/m2 body surface area/monthly by intravenous infusion.total 6cycle will be given

Primary Outcome Measures

Name	Time	Method
skin thickness	24 weeks after initiation of treatment	skin thickness measured by modified rodnan skin score

Secondary Outcome Measures

Name	Time	Method
joint pain	24 weeks after initiation of treatment	measured by clinical disease activity index

Trial Locations

Locations (1)

Nabil Amin Khan; 🇧🇩 Dhaka, Shahbag, Bangladesh