Clinical trial NCT06044844: Effectiveness of Tofacitinib in Systemic Sclerosis
Official title: A Study Evaluating the Effectiveness of Tofacitinib in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Efficacy of Tofacitinib in the Systemic Sclerosis
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
Collaborators: name: Aristopharma Ltd
First posted: 2023-09-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: skin thickness
timeFrame: 24 weeks after initiation of treatment
Secondary outcomes:
measure: joint pain
timeFrame: 24 weeks after initiation of treatment
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Nabil Amin Khan
state: Shahbag
Study officials:
affiliation: resident
name: Nabil Khan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: