Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
44 participants
INTERVENTIONAL
2023-11-30
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis
tab tofacitinib 5mg twice daily will be given by oral route for 6month
Tofacitinib
tofacitinib efficacy
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
Tofacitinib
tofacitinib efficacy
Interventions
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Tofacitinib
tofacitinib efficacy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
OTHER
Aristopharma Ltd
INDUSTRY
Responsible Party
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Nabil Amin Khan
Resident,rheumatology
Principal Investigators
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Nabil Khan, MBBS
Role: PRINCIPAL_INVESTIGATOR
resident
Locations
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Nabil Amin Khan
Dhaka, Shahbag, Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4137
Identifier Type: -
Identifier Source: org_study_id
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