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Effectiveness of Tofacitinib in Systemic Sclerosis

Primary Purpose

Efficacy of Tofacitinib in the Systemic Sclerosis

Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Tofacitinib
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy of Tofacitinib in the Systemic Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nabil Amin KhanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis

efficacy of Cyclophosphamide in early diffuse cutaneous systemic sclerosis

Arm Description

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

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

Outcomes

Primary Outcome Measures

skin thickness
skin thickness measured by modified rodnan skin score

Secondary Outcome Measures

joint pain
measured by clinical disease activity index

Full Information

First Posted
June 7, 2023
Last Updated
September 18, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators
Aristopharma Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06044844
Brief Title
Effectiveness of Tofacitinib in Systemic Sclerosis
Official Title
A Study Evaluating the Effectiveness of Tofacitinib in Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators
Aristopharma Ltd

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy of Tofacitinib in the Systemic Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis
Arm Type
Experimental
Arm Description
tab tofacitinib 5mg twice daily will be given by oral route for 6month
Arm Title
efficacy of Cyclophosphamide in early diffuse cutaneous systemic sclerosis
Arm Type
Experimental
Arm Description
injection cyclophosphamide 500mg/m2 body surface area/monthly by intravenous infusion.total 6cycle will be given
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Other Intervention Name(s)
Tab Arthanib
Intervention Description
tofacitinib efficacy
Primary Outcome Measure Information:
Title
skin thickness
Description
skin thickness measured by modified rodnan skin score
Time Frame
24 weeks after initiation of treatment
Secondary Outcome Measure Information:
Title
joint pain
Description
measured by clinical disease activity index
Time Frame
24 weeks after initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil khan, MBBS
Phone
+8801723441428
Email
nabilkaku@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil Khan, MBBS
Phone
01516173213
Email
nabilamin16@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil Khan, MBBS
Organizational Affiliation
resident
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nabil Amin Khan
City
Dhaka
State/Province
Shahbag
ZIP/Postal Code
1217
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabil Khan, MBBS
Phone
+8801516173213
Email
nabilkaku@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Tofacitinib in Systemic Sclerosis

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