CompletedPhase 3

Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)

United States95 participantsStarted 2017-02-27

Plain-language summary

Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")

Who can participate

Age range18 Years – 79 Years

SexALL

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Inclusion criteria

✓. Subjects with diagnosis of definite or probable DM according to the Bohan and Peter criteria.
✓. Subjects under treatment with corticosteroids and/or maximally 2 immune-suppressants and being on stable therapy for at least 4 weeks (see Section 4.2.1) OR Subjects with previous failure of response or previous intolerance to corticosteroid and at least 1 additional immunosuppressive drug, and with steroid/immunosuppressive drugs washed out as per Section 4.2.1 (Table 2).
✓. Subjects with active disease, assessed and agreed upon by an independent adjudication committee.
✓. Manual Muscle Testing-8 (MMT-8) score \<142, with at least 2 other abnormal Core Set Measures (CSM) (Visual Analogue Scale \[VAS\] of patient global activity ≥2 cm, physician's global disease activity ≥2 cm, extra-muscular activity ≥2 cm; at least one muscle enzyme \>1.5 times upper limit of normal, Health Assessment Questionnaire ≥0.25).
✓. Males or females ≥ 18 to \< 80 years of age.
✓. Voluntarily given, fully informed written consent obtained from subject before any study-related procedures are conducted.
✓. Subject must be capable to understand and comply with the relevant aspects of the study protocol.

Exclusion criteria

✕. Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured and at least 1 or 5 years, respectively, have passed since excision).
✕. Evidence of active malignant disease or malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors) or breast cancer diagnosed within the previous 10 years.
✕. Subjects with overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, juvenile dermatomyositis or drug-induced myopathy.
✕. Subjects with immune-mediated necrotizing myopathy with absence of typical DM rash.
✕. Subjects with generalized, severe musculoskeletal conditions other than DM that prevent a sufficient assessment of the subject by the physician.
✕. Subjects who have received IgG treatment within the last 6 months before enrolment.
✕. Subjects who received blood or plasma-derived products (other than IgG) or plasma exchange within the last 3 months before enrolment.
✕. Subjects starting or planning to start a physical therapy-directed exercise regimen during the trial.

What they're measuring

Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS)

Timeframe: At week 16

Trial details

NCT IDNCT02728752

SponsorOctapharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-05

Results submitted2020-11-02

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