A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease

• Conditions: Polymyositis / Dermatomyositis; MedDRA version: 16.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 16.0Level: PTClassification code 10036102Term: PolymyositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-005772-34-ES
• Lead Sponsor: aboratorios Servier S.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-10
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Active polymyositis or dermatomyositis intolerant or resistant or dependent to systemic oral corticosteroids,
- Disease diagnosis duration ? 6 years,
- With a stable background treatment of oral corticosteroid if any and / or a stable dose of immunosuppressive agent if any.
- Male or female, age ? 18 (or legal age of majority in the country),
- Weight ?40 kg and ? 125 kg at selection,
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Juvenile dermatomyositis, drug induced myositis, severity criteria such as severe cardiovascular or pulmonary involvement or myositis damage, necrotizing myopathy, inclusion body myositis, cancer- associated myositis or DM diagnosed for less than 1 year,
- Impossibility to perform muscle biopsy for PM patients (if required),
- Non-ambulatory patients,
- Fibromyalgia of type I,
- Joint disease or other musculoskeletal condition,
- Active TB disease,
- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- History of malignancy within 5 years prior to selection,
- Known immunodeficiency,
- Infectious disease,
- Pregnancy, breastfeeding or possibility to become pregnant during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified