Status:
TERMINATED
Canakinumab for Treatment of Adult-onset Still's Disease
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Adult-Onset Still´s Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to investigate the efficacy of the treatment with canakinumab in participants with Adult-onset Still's Disease (AOSD) and active joint involvement.
Eligibility Criteria
Inclusion
- Written and signed consent from the participant to take part in the study
- Men and women aged ≥ 18 years and ≤ 75 years
- Fulfilment of AOSD classification criteria (according to Yamaguchi et al, J. Rheumatology, 1992)
- Disease activity based on Disease Activity Score 28 (DAS28) of ≥3.2 at screening
- At least 4 painful and 4 swollen joints at screening and baseline (of the 28 joints according to DAS28)
- If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable dose for at least 4 weeks prior to randomisation
- If undergoing treatment with glucocorticoids, stable dose of ≤10 milligrams per day (mg/day) (prednisolone or equivalent) for at least 4 weeks prior to randomisation
- If undergoing treatment with conventional disease-modifying anti-rheumatic drugs (DMARD), stable dose for at least 3 months prior to randomisation
- Normalisation period for biological DMARDS (anakinra 1 week, etanercept 1 month, adalimumab and certolizumab 2 months, infliximab, golimumab, abatacept and tocilizumab 3 months, rituximab 9 months, canakinumab 6 months) prior to randomisation
- In participants of reproductive age, use of an effective method of contraception as well as negative pregnancy test prior to the study commencing.
Exclusion
- Previous treatment with the study drug with repeated administration of canakinumab
- Intraarticular or intravenous administration of glucocorticoids within 4 weeks prior to the baseline or use of narcotic analgesics except for analgesics permitted within the framework of the investigation (codeine and tramadol)
- Presence of another, serious chronic-inflammatory disease
- Positive hepatitis B antigen (HBsAg), hepatitis C antibodies and/or human immunodeficiency virus (HIV) antibodies.
- Presence of a relevant, active infection or other diseases, which entail a tendency towards infection
- Positive screening for latent tuberculosis, in accordance with usual local practice
- Raised liver count (raised bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-fold the normal range)
- Serum-creatinine concentration \>1.5 milligrams per deciliter (mg/dL)
- Inadequate haematological findings (hemoglobin \[Hb\] ≤ 10 grams per deciliter (g/dL), neutrophils ≤2,500/microliter (µl) and thrombocytes ≤100,000/µl)
- Simultaneous participation in any other interventional clinical study within the last 30 days preceding the commencement of the study
- History of neoplasia with the exception of a curatively treated non-melanoma skin tumour or carcinoma of the cervix treated in situ without any indication of recurrence within the last 10 years
- Relevant cardiac or pulmonary disorders
- Severe intercurrent neurological or psychiatric disorders
- Macrophage activation syndrome (MAS) as part of previous treatment with IL-1 blockade (e.g. anakinra, rilonacept)
- Vaccination with a live vaccine within 3 months before the baseline
- Alcohol or drug abuse in the past 12 months
- ≥400 milliliter (mL) donation of blood or loss up to 8 weeks before the baseline
- Pregnancy or breast-feeding
- Commitment of the patient to an institution at the direction of an authority or court
Key Trial Info
Start Date :
June 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02204293
Start Date
June 21 2012
End Date
May 5 2018
Last Update
August 7 2020
Active Locations (14)
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1
Charité Campus Mitte
Berlin, Germany, 10117
2
Immanuel Krankenhaus Berlin
Berlin, Germany, 13125
3
Med. Klinik I für Innere Medizin Köln
Cologne, Germany, 50937
4
Universität Erlangen
Erlangen, Germany, 91054