To study the benefits of starting the drug named Mycophenolate Mofetil early in the treatment of myositis patients.
Phase 3
- Conditions
- Health Condition 1: M608- Other myositis
- Registration Number
- CTRI/2023/11/059542
- Lead Sponsor
- DrFathima Nilofar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients aged more than 16 years of age diagnosed with Idiopathic Inflammatory Myositis.
Patients were classified in to Primary adult Polymyositis, Primary adult Dermatomyositis and Inclusion Body Myositis.
Exclusion Criteria
Patients below 16 years of age.
patients with Endocrine disorders like thyroid and diabetes mellitus.
patients with inherited muscle dystrophy.
patients with paraneoplastic myositis and overlap myositis.
patients with drug induced myositis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the improvement in muscle strength using Manual Muscle Testing procedure(MMT 8 <br/ ><br>)in patients treated with idiopathic inflammatory myositis after induction therapyTimepoint: Baseline, 6 weeks , 12 weeks ,24 weeks
- Secondary Outcome Measures
Name Time Method 1.Muscle enzyme-CPK levels <br/ ><br>2.C-reactive protein & LDH levels <br/ ><br>3.Steroid Related side effects <br/ ><br>4.Assessment of Disease Activity using MyoAct & MITAX scoring system <br/ ><br>5.No of patients with treatment failure <br/ ><br>6.Total dose of glucocorticoid in mg/kg which will be administered for initial 6 months of treatmentTimepoint: Baseline, 6 weeks, 24 weeks