Effectiveness of Tofacitinib in Systemic Sclerosis

NCT06044844 | Unknown Phase 2 DMC

• 1 other identifier: 4137
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 .

Conditions

Efficacy of Tofacitinib in the Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• skin thickness

  skin thickness measured by modified rodnan skin score

  24 weeks after initiation of treatment

Secondary Outcomes (1)

• joint pain

  24 weeks after initiation of treatment

Study Arms (2)

efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis

EXPERIMENTAL

tab tofacitinib 5mg twice daily will be given by oral route for 6month

Drug: Tofacitinib

efficacy of Cyclophosphamide in early diffuse cutaneous systemic sclerosis

EXPERIMENTAL

injection cyclophosphamide 500mg/m2 body surface area/monthly by intravenous infusion.total 6cycle will be given

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

tofacitinib efficacy

Also known as: Tab Arthanib

efficacy of Cyclophosphamide in early diffuse cutaneous systemic sclerosis; efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis

Eligibility Criteria

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

You may qualify if:

• Diagnosis of SSc, as classified using the 2013 American College of Rheumatology
• dcSSc as defined by 2001 LeRoy and Medsge
• Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation)
• mRSS units ≥ 10 and ≤ 45 at screening.
• 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.
• Calcium channel blocker and PDFE-5 inhibitors for Raynaud's and digital ulcers are permitted to use as oral monotherapy
• Age ≥ 18 years and ≤ 70 years
• Ability to provide informed consent.

You may not qualify if:

• Subjects with any of the following characteristics/conditions will not be included in the study:
• Any infection at screening .
• Oral corticosteroids \>10 mg/day of prednisone or equivalent.
• Pulmonary disease with FVC ≤ 35% of predicted.
• 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
• Latent TB at or within 30 days of screening.
• 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.
• 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.
• 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 with the exception of adequately treated or excised basal cell or squamous cell or cervical cancer in situ.
• History of SSc Renal Crisis within the 6 months prior to baseline.
• History of live/attenuated vaccine ≤ 6 weeks prior to baseline
• Any of the following lab results at screening:

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead
• Aristopharma Ltd: collaborator

Study Sites (1)

Nabil Amin Khan

Dhaka, Shahbag, 1217, Bangladesh

RECRUITING

MeSH Terms

Interventions

tofacitinib

Study Officials

• Nabil Khan, MBBS

  resident

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil khan, MBBS

CONTACT

+8801723441428; nabilkaku@gmail.com

Nabil Khan, MBBS

CONTACT

01516173213; nabilamin16@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident,rheumatology

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: September 21, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)