Status:
UNKNOWN
Effectiveness of Tofacitinib in Systemic Sclerosis
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborating Sponsors:
Aristopharma Ltd
Conditions:
Efficacy of Tofacitinib in the Systemic Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion Criteria:
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06044844
Start Date
November 1 2023
End Date
May 1 2024
Last Update
September 21 2023
Active Locations (1)
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1
Nabil Amin Khan
Dhaka, Shahbag, Bangladesh, 1217