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Clinical Trials/CTRI/2019/02/017795
CTRI/2019/02/017795
Not yet recruiting
未知

A randomised controlled trial comparing the efficacy and safety of rituximab, intravenous cyclophosphamide pulse and mycophenolate mofetil in systemic sclerosis.

ICMR grant applied0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: M349- Systemic sclerosis, unspecified

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: M349- Systemic sclerosis, unspecified
Sponsor
ICMR grant applied
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
ICMR grant applied

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with a diagnosis of systemic sclerosis as per the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, irrespective of their gender, will be included in the study. They may have either diffuse cutaneous or limited cutaneous systemic sclerosis.
  • •2\. Age \>\=12 years
  • •3\. Patients with the following evidence of pulmonary involvement:
  • •% predicted FVC \<\= 70% and/or
  • •HRCT chest showing involvement of \>\= 20% of lung area with interstitial lung disease.

Exclusion Criteria

  • •1\. Patients with overlap syndrome.
  • •2\. Diagnosis of clinically significant resting pulmonary hypertension requiring treatment diagnosed on echocardiography (defined as tricuspid regurgitation velocity \>\= 4m/s, eqivalent to estimated pulmonary artery systolic pressure of 64 mm Hg) while evaluation of the patient during study.
  • •3\. Evidence of uncontrolled congestive heart failure, unstable ischemic heart disease, history of pulmonary embolism, or cardiac arrhythmia requiring chronic anticoagulation.
  • •4\. FVC \<\= 15% at baseline.
  • •5\. Patients who cannot perform spirometry for evaluation of pulmonary function tests despite sufficient counselling about the procedure.
  • •6\. More than 50% area of lung showing fibrosis on HRCT chest at baseline.
  • •7\. Hematologic abnormality at screening including:
  • •Leukopenia (white blood cells \[WBC] \< 4\.0x103/µl).
  • •Thrombocytopenia (platelet count \< 150\.0x103/µl).
  • •Clinically significant anemia (hemoglobin \< 7 g/dl).

Outcomes

Primary Outcomes

Not specified

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