At a glance
ClinicalIndex Comparison Record- ✓Adults with definite or probable dermatomyositis or polymyositis; pediatric patients ≥5 years with definite or probable juvenile dermatomyositis (JDM) diagnosed by Bohan and Peter criteria with onset <18 years.
- ✓Refractory myositis: inadequate response to corticosteroids plus an adequate regime of at least one other immunosuppressive agent, or intolerance requiring discontinuation.
- ✓Adults with DM/PM: baseline MMT-8 score ≤125/150 with ≥2 other abnormal core set measures. JDM: MMT-8 ≤125/150 with ≥2 other abnormal measures, OR MMT-8 >125/150 with ≥3 abnormal core set measures.
- ✓Background therapy with ≥1 non-corticosteroid immunosuppressive agent at stable dose for ≥6 weeks prior to screening.
- ✕Drug-induced myositis from statins, fibric acid derivatives, colchicine, hydroxychloroquine, or other myositis-inducing medications.
- ✕Juvenile polymyositis.
- ✕Inclusion body myositis.
- ✕Cancer-associated myositis (diagnosis within 2 years of cancer diagnosis); exception: basal/squamous cell skin cancer or cervical carcinoma in situ if ≥5 years since excision.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathy (IIM)
In Brief
A Phase 2 clinical trial evaluating Rituximab and Placebo for Myositis and 3 related conditions. Completed, enrolled 200 participants across 31 sites in 4 countries.
Detailed Summary
Rituximab is a man-made antibody used to treat certain types of cancer. This study will determine whether rituximab is an effective treatment for adult and pediatric patients with dermatomyositis or polymyositis. Study hypotheses: 1) The time to improvement in Group A patients (receiving rituximab first) will occur significantly earlier than in Group B patients (receiving rituximab later). 2) The proportion of patients improved at Week 8 of the treatment phase will be significantly greater in Group A than in Group B.
Study Details
Timeline
Interventions
Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Group B - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum does of 1 gram at Weeks 8 and 9
Treatment Group A: placebo infusion at Weeks 8 and 9 Treatment Group B: placebo infusion at Weeks 0 and 1