Health Condition 1: G724- Inflammatory and immune myopathies, not elsewhere classified
Conditions
Interventions
Intervention1: Rituximab: 1000 mg intravenous rituximab on days 1 and 15, administered per standard protocol with premedication
Duration : 6 months
Control Intervention1: Standard of care immunosu
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (Age more than or equal to 12 yrs) with definite or probable PM or DM (2017 EULAR ACR classification criteria for adult IIM) 2. Treatment na ve or patients who have received steroid alone for less than 1 month 3. All patients must have a biopsy consistent with diagnosis of PM or DM 4. Adult PM or DM should have Manual Muscle Testing 8 (MMT 8) score less than or equal to142/150 and at least 2 of the following: PGA more than or equal to 2.0 cm (VAS 10 cm scale). PtGA more than or equal to 2.0 cm (VAS 10 cm scale). HAQ-DI more than or equal to 0.25. One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) more than or equal to 1.3 ULN. Global extra muscular disease activity (MDAAT) more than or equal to 1.0 cm (VAS 10 cm scale) 5. Fulfill one of the following criteria of active disease at screening: a. Muscle enzyme elevation of CK more than or equal to 4 times ULN b. Muscle enzyme elevation of CK more than or equal to one times ULN and less than four times ULN with at least one of the following: Muscle MRI performed within 1 months prior to Day 1 (randomization) with evidence of muscle inflammation Muscle biopsy performed within 2 months prior to Day 1 (randomization) that demonstrates active inflammation. EMG performed within 1 month of Day 1 (randomization) that exhibits irritable myopathic pattern.
Exclusion criteria
Exclusion criteria: 1.PM or DM having bulbar weakness requiring mechanical ventilation 2. IMNM, Inclusion Body Myositis (IBM), or myositis other than IIM, eg, drug induced myositis and PM associated with HIV, Cancer associated myositis 3. Pregnancy and lactating mothers, Pregnancy detected by UPT 4.Patients treated with penicillamine or zidovudine in the past 3 months 5.Subjects treated with rituximab in the past or any other biologic treatment or Intravenous Immunoglobulin (IVIG) 6.Patients with uncontrolled or rapidly progressive interstitial lung disease 7.Patients with severe muscle damage (Myositis Damage Index more than 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement 8.Active Tuberculosis HRCT Chest or Sputum AFB 9.Severe calcinosis, HMGCR or SRP autoantibodies positive 10.HIV, HCV, Hepatitis B patient not on Tenofovir 11.Hepatitis B total core antibody positive patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieved Total Improvement Score (TIS) more than or equal to 40 (indicating at least moderate improvement)Timepoint: At week 24 (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative corticosteroid useTimepoint: At week 24 (6 months);CDASI-activity change from baseline (for DM patients)Timepoint: At week 8 and 24;Change in following scores from baseline PGA PtGA Muscle enzymes MDAAT extra-muscular disease activity HAQ-DI Timepoint: At Weeks 8, 24 and 52;Proportion of participants who will achieve Total Improvement Score (TIS) more than or equal to 20 (indicating at least mild improvement)Timepoint: At week 8 and 24;Proportion of participants who will achieve Total Improvement Score (TIS) more than or equal to 60 (indicating major improvement)Timepoint: At week 8 and 24;Change in MMT 8Timepoint: At week 24;Proportion of participants who will require steroids dose more than 7.5 mg/day beyond 3 monthsTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactAashka Shah
AIIMS New Delhi
Outcome results
None listed