polymyositis and dermatomyositis MedDRA version: 12.1 Level: LLT Classification code 10036102 Term: Polymyositis MedDRA version: 12.1 Level: LLT Classification code 10012503 Term: Dermatomyositis
Conditions
Interventions
Trade Name: ORENCIA
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with definite or probable polymyositis or dermatomyositis diagnosed according to the diagnostic criteria by Bohan and Peter (30,31). 2. For polymyositis a muscle biopsy is required that confirmed this disease (performed at any time before the start of the study) and to exclude other conditions unless a patient is positive for myositis specific or myositis associated autoantibodies. 3. Polymyositis will be included after a judicial process by the three PIs. 4. Inflammatory active disease based on persisting or worsening muscle weakness, MMT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with other types of inflammatory myopathies including - Drug induced myositis. - Inclusion body myositis - Malignancy associated myositis. 2. Women who are pregnant or breastfeeding. 3. Women with a positive pregnancy test on enrolment or prior to start of study drug administration. 4. Women of Child Bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 10 weeks after the last infusion of study medication. 5. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease with the exception of those symptoms that are a manifestation of polymyositis or dermatomyositis. Concomitant medical conditions that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study. 6. Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Patients with dermatomyositis need to be screened for malignancies according to routine procedures. 7. Subjects who have a history of clinically significant drug or alcohol abuse. Subjects currently taking methotrexate who admit to consumption of more than an average of 1 alcoholic drink per day. 8. Subjects with any serious bacterial infection (such as pneumonia, other renal infection and sinusitis), unless treated and resolved with antibiotics or chronic bacterial infection (such as pyelonephritis and chest infection with bronchiectasis) in the previous 3 months. 9. Subjects with active tuberculosis requiring treatment within the previous 3 years. Subjects with a positive PPD at screening will not be eligible for the study unless they completed treatment for latent TB and have a negative chest x-ray at enrolment. A PPD response that is equal to or greater than 10 mm should be considered a positive test, although more conservative criteria may be applied as determined by the clinical circumstance and investigator according to published guidelines and/or local standards endorsed by the medical society. Quantiferon assay may replace PPD testing and patients are excluded from the study if the test is positive. Quantiferon positive patients who completed treatment for latent tuberculosis according to the local guidelines may be considered for enrolment. 10. Subjects with herpes zoster that resolved less than 2 months prior to enrolment. 11. Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrolment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection. 12. Significant toxicities associated with concomitant or previous immunosuppressive Therapy and anti-TNF therapy that would preclude subjects from participating and completing the study 13. Patients with clinically apparent immunodeficiency syndrome, (IgA deficiency alone is not an exclusion criterion) 14. Subjects with any of the following laboratory values: • Hgb 2 times upper limit of normal. • Any other laboratory test results that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. 15. Subjects previously tre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the clinical efficacy of abatacept on disease activity in polymyositis, and dermatomyositis patients as defined by the International Myositis Outcome Assessment Collaborative Study (IMACS) group.;Secondary Objective: The secondary objectives: • The number of responders in the delayed onset arm compared with active treatment arm at 3 and 6 months • The change in the individual components of the IMACS core set measures for disease activity in the delayed onset arm compared with active treatment arm at 3 and 6 months • The change in the muscle endurance as tested by the myositis functional index (FI-2) in the delayed onset arm compared with active treatment arm at 3 and 6 months • Time to improvement To investigate the efficacy after 6 months with active treatment on the following variables: • The individual components of the IMACS core set measures for disease activity • Muscle endurance as tested by the myositis functional index (FI-2) • Health related quality of life assessed by SF-36 • On signs of inflammation in muscle tissue (repeated muscle biopsies) Explorative objective: To investigate the role of T cells in disease mechanisms of polymyositis and dermatomyositis. ;Primary end point(s): The number of responders, defined as improved according the IMACS criteria, after treatment with abatacept for six months. Preliminary Definition of improvement (DOI) The definition of improvement is based on a core set of clinical and laboratory variables to assess disease activity, an outcome measure developed in an international consensus, recommended for use in clinical trials by the IMACS group. Any 3 of 6 core set measures improved = 20% with no more than 2 (not including MMT) worse by = 25%. | — |
Countries
Sweden, United Kingdom
Outcome results
None listed