Effectiveness of Tofacitinib in Systemic Sclerosis

A Study Evaluating the Effectiveness of Tofacitinib in Systemic Sclerosis

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

Study Overview

• Status: Recruiting
• Conditions: Efficacy of Tofacitinib in the Systemic Sclerosis
• Intervention / Treatment: Drug: Tofacitinib

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nabil khan, MBBS; Phone Number: +8801723441428; Email: nabilkaku@gmail.com
• Study Contact Backup: Name: Nabil Khan, MBBS; Phone Number: 01516173213; Email: nabilamin16@yahoo.com

Study Locations

• Bangladesh
  • Shahbag
    • Dhaka, Shahbag, Bangladesh, 1217
      • Recruiting
      • Nabil Amin Khan
      • Contact: Nabil Khan, MBBS; Phone Number: +8801516173213; Email: nabilkaku@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Inclusion criteria:

  1. Diagnosis of SSc, as classified using the 2013 American College of Rheumatology
  2. dcSSc as defined by 2001 LeRoy and Medsge
  3. Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation)
  4. mRSS units ≥ 10 and ≤ 45 at screening.
  5. Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) are permitted if the patient is on a stable dose regimen for ≥ 2 weeks prior to and including the baseline visit.
  6. Calcium channel blocker and PDFE-5 inhibitors for Raynaud's and digital ulcers are permitted to use as oral monotherapy
  7. Age ≥ 18 years and ≤ 70 years
  8. Ability to provide informed consent.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis; tab tofacitinib 5mg twice daily will be given by oral route for 6month	Drug: Tofacitinib; tofacitinib efficacy; Other Names: Tab Arthanib
Experimental: efficacy of Cyclophosphamide in early diffuse cutaneous systemic sclerosis; injection cyclophosphamide 500mg/m2 body surface area/monthly by intravenous infusion.total 6cycle will be given	Drug: Tofacitinib; tofacitinib efficacy; Other Names: Tab Arthanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin thickness	skin thickness measured by modified rodnan skin score	24 weeks after initiation of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
joint pain	measured by clinical disease activity index	24 weeks after initiation of treatment

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Collaborators: Aristopharma Ltd
• Investigators: Principal Investigator: Nabil Khan, MBBS, Resident

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: 4137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No