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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00106184
Other study ID # N01AR42273
Secondary ID 5R01AR061298-02H
Status Completed
Phase Phase 2
First received March 21, 2005
Last updated March 3, 2015
Start date March 2006
Est. completion date August 2010

Study information

Verified date March 2015
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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Other known NCT identifiers
  • NCT00393237

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Rituximab
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
Placebo
Treatment Group A: placebo infusion at Weeks 8 and 9 Treatment Group B: placebo infusion at Weeks 0 and 1

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Sponsors (4)

Lead Sponsor Collaborator
University of Pittsburgh Biogen, Genentech, Inc., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Sweden, 

References & Publications (3)

Feldman B, Wang E, Willan A, Szalai JP. The randomized placebo-phase design for clinical trials. J Clin Epidemiol. 2001 Jun;54(6):550-7. — View Citation

Levine TD. Rituximab in the treatment of dermatomyositis: an open-label pilot study. Arthritis Rheum. 2005 Feb;52(2):601-7. — View Citation

Oddis CV, Reed AM, Aggarwal R, Rider LG, Ascherman DP, Levesque MC, Barohn RJ, Feldman BM, Harris-Love MO, Koontz DC, Fertig N, Kelley SS, Pryber SL, Miller FW, Rockette HE; RIM Study Group. Rituximab in the treatment of refractory adult and juvenile derm — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by = 20%, with no more than 2 of the core set measures worsening by =25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.
Core Set Measures Included:
Manual Muscle Testing (MMT)- Muscle Strength
Physician Global Disease Activity VAS Score
Health Assessment Questionnaire Index Score - Physical Function
Patient Global Assessment of Disease Activity VAS score
Extramuscular Activity - Myositis Disease Activity Assessment Tool
2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)
Week 44 of treatment phase No
Secondary Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8 The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by = 20%, with no more than 2 of the core set measures worsening by =25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.
Core Set Measures Included:
Manual Muscle Testing (MMT)- Muscle Strength
Physician Global Disease Activity VAS Score
Health Assessment Questionnaire Index Score - Physical Function
Patient Global Assessment of Disease Activity VAS score
Extramuscular Activity - Myositis Disease Activity Assessment Tool
2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)
Week 8 of the treatment phase No
Secondary 20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI]) Number of participants with a 20% improvement in MMT over baseline on two consecutive time points. Week 44 of treatment phase No
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