Safety and efficacy of Abatacept in patients with treatment-resistant sarcoidosis

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Signed written informed consent
2. Diagnosis of sarcoidosis according to current applicable ATS/WASOG guidelines
3. Immunosuppressive therapy (>5mg prednisolone equivalent per day or additional immunsuppressive therapy) within the last 3 months prior screening
4. Kings Sarcoidosis Questionnaire (KSQ): Score < 80
5. Need for therapy escalation beyond 5 mg prednisolone equivalent according to the physician’s appraisal
6. Elevated sIL2 receptor levels and /or elevated Neopterin as sign of T-cell activation within 6 months prior to date of informed consent

Exclusion Criteria

1. Severe lung functional impairment according to the treating physician interfering substantially with participation in the trial
2. End stage fibrotic lung disease without expected improvement to immunosuppressive therapy as judged by the treating physician
3. Concomitant lung disease (e.g. COPD, asthma) that interferes with clinical assessment as judged by the treating physician
4. Concurrent immunosuppressive therapy other than corticosteroids and impossibility to allow a sufficient wash-out phase
5. For biologicals a wash-out phase of two months is mandatory
6. Previous treatment with Abatacept
7. Treatment with another investigational drug within 4 weeks or 5 half-lives prior to first application of trial medication
8. Recurrent or active current bacterial, viral or fungal infection (excluding fungal infections of the nails)
9. History of or active psychiatric disease interfering with the safe participation in the study
10. History of or current primary or secondary immunodeficiency that could not be attributable to treatment-related immunodeficiency
11. Serious uncontrolled concomitant diseases not caused by sarcoidosis
12. Known malignancy or high clinical suspicion on malignant disease
13. Lymphoma within the last five years
14. Contraindications against treatment with Abatacept
15. Simultaneous application of live vaccines
16. Simultaneous participation in other interventional clinical trials
17. Pregnancy indicated by positive urine pregnancy test
18. Breast-feeding patients
19. Fertile patients refusing to use safe contraceptive methods during the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number and characterization of severe infectious complications during Abatacept treatment period

Secondary Outcome Measures

Name	Time	Method

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