To study the benefits of starting the drug named Mycophenolate Mofetil early in the treatment of myositis patients.

Mycophenolate Mofetil for induction and as steroid sparing agent in the treatment of Idiopathic Inflammatory Myositis-An open Labeled study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059542

Enrollment

Registered

2023-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M608- Other myositis

Interventions

Intervention1: Mycophenolate Mofetil PLUS GLUCOCORTICOIDS: Mycophenolate Mofetil administered orally starting from 250-500 mg twice a day up to 2-3 gram daily dose for a period of 6 months Along with

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To assess the improvement in muscle strength using Manual Muscle Testing procedure(MMT 8 )in patients treated with idiopathic inflammatory myositis after induction therapyTimepoint: Baseline, 6 weeks , 12 weeks ,24 weeks	—

Secondary

Measure	Time frame
1.Muscle enzyme-CPK levels 2.C-reactive protein & LDH levels 3.Steroid Related side effects 4.Assessment of Disease Activity using MyoAct & MITAX scoring system 5.No of patients with treatment failure 6.Total dose of glucocorticoid in mg/kg which will be administered for initial 6 months of treatmentTimepoint: Baseline, 6 weeks, 24 weeks	—

Countries

India

Contacts

Public ContactDr.Mahendra Kumar

Saveetha Medical college and Hospital

mahindran1985@gmail.com9445645171

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026