muscle disorder polymyositis
Conditions
Interventions
None listed
Sponsors
PRA Belgium BVBA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female * 18 years and 1000 U/L at Screening. 7. No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the first 8-weeks on study. 8. No changes in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the first 8-weeks on study. 9. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to the first dose of study drug. 10. Sexually active female subjects of childbearing potential (i.e., women who are not postmenopausal or who have not had a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) and all male subjects (who have not been surgically sterilized by vasectomy) must agree to use effective contraception during the study. Postmenopausal women are, for the purposes of this protocol, defined as women who have gone 12 consecutive months without menstruation.
Exclusion criteria
Exclusion criteria: 1. History of meningococcal disease. 2. Current or recent systemic infection within 2 weeks prior to Screening or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Screening. 3. Pregnant, planning to become pregnant, or nursing female subjects. 4. Recent surgery requiring general anesthesia within 2 weeks prior to Screening or expected to have surgery requiring general anesthesia during the 8-week Treatment Period. 5. Treatment with a complement inhibitor or an experimental drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Baseline. 6. Statin use within 30 days prior to Baseline or anticipated to occur during study. 7. Rituximab use within 90 days prior to Baseline or anticipated to occur during study. NOTE: In subjects who received rituximab more than 90 days but less than 6 months prior to Baseline, prophylactic antibiotics (e.g., ciprofloxacin, erythromycin, penicillin V) should be given upon initiation of study drug until 6 months after the last rituximab dose. 8. Recent initiation of intravenous immunoglobulin (IVIG) (i.e., first cycle administered less than 90 days prior to Baseline). 9. Plasma exchange within 4 weeks prior to Baseline or expected to occur during the 8-week Treatment Period. 10. Active malignancy (except curatively resected squamous or basal cell carcinoma of the skin) requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to Screening with no detectable recurrence are allowed). 11. History of any significant medical, psychiatric disorder, or laboratory abnormality that in the opinion of the investigator would make the subject unsuitable for participation in the study. 12. Participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted). 13. Unable or unwilling to comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Percent change from Baseline to Week 8 in CK levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Change from Baseline to Week 8 in Triple Timed Up and Go (3TUG) Test (in ambulatory subjects only) * Change from Baseline to Week 8 in Proximal Manual Muscle Testing (MMT) * Change from Baseline to Week 8 in Physician Global Activity Visual Analogue Scale (VAS) * Change from Baseline to Week 8 in Patient Global Activity VAS * Change from Baseline to Week 8 in Health Assessment Questionnaire (HAQ) * Change from Baseline to Week 8 in Myositis Disease Activity Assessment Tool (MDAAT) Score * Change from Baseline to Week 8 in American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Response Criteria * Change from Baseline to Week 8 in FACIT-Fatigue Scale | — |
Countries
Netherlands
Outcome results
None listed