Canakinumab for Treatment of Adult Onset Still's Disease
Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult-Onset Still´s Disease
Intervention: Canakinumab (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Eugen Feist, PD Dr, Principal Investigator, Affiliation: Charité University Berlin Germany
Overall contact:
Eugen Feist, PD Dr, Phone: +4930450513025, Email: eugen.feist@charite.de
Summary
Interleukin-1 antagonists such as canakinumab have been used for the treatment of AOSD and
have had a marked influence on the activity of the disease, including joint mobility.
Results from controlled clinical studies are not, however, currently available.
Clinical Details
Official title: Canakinumab for Treatment of Adult Onset Still's Disease to Achieve Reduction of Arthritic Manifestation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Efficacy of canakinumab with a clinically-significant reduction in disease activity
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Written and signed consent from the patient to participate in the study
2. Men and women aged ≥ 18 years and ≤ 75 years
3. Fulfilment of AOSD classification criteria (according to Yamaguchi et al, J.
Rheumatology, 1992)
4. Disease activity based on DAS28 of ≥3. 2 at screening
5. At least 4 painful and 4 swollen joints at screening and baseline (of the 28 joints
according to DAS28)
6. If undergoing treatment with NSAIDs, stable dose for at least 4 weeks prior to
randomisation
7. If undergoing treatment with glucocorticoids, stable dose of ≤10 mg/day (prednisolone
or equivalent) for at least 4 weeks prior to randomisation
8. If undergoing treatment with conventional DMARD, stable dose for at least 3 months
prior to randomisation
9. Normalisation period for biological DMARDS (Anakinra 1 week, Etanercept 1 month,
Adalimumab and Certolizumab 2 months, Infliximab, Golimumab, Abatacept and
Tociluzumab 3 months, Rituximab 9 months, canakinumab 6 months) prior to
randomisation
10. In patients of reproductive age, use of an effective method of contraception as well
as negative pregnancy test prior to the study commencing.
Exclusion Criteria:
1. Previous treatment with the study drug with repeated administration of canakinumab
2. 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)
3. Presence of another, serious chronic-inflammatory disease
4. Positive Hepatitis B antigen (HBsAg), Hepatitis C antibodies and/or HIV antibodies.
5. Presence of a relevant, active infection or other diseases, which entail a tendency
towards infection.
6. Positive screening for latent tuberculosis, in accordance with usual local practice
7. Raised liver count (raised bilirubin; ALT or AST ≥3-fold the normal range)
8. Serum-creatinine concentration >1. 5 mg/dl
9. Inadequate haematological findings (Hb ≤ 10 g/dl, neutrophils ≤2,500/µl and
thrombocytes ≤100,000/µl)
10. Simultaneous participation in any other interventional clinical study within the last
30 days preceding the commencement of the study
11. 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
12. Relevant cardiac or pulmonary disorders
13. Severe intercurrent neurological or psychiatric disorders
14. Macrophage activation syndrome (MAS) as part of previous treatment with IL-1 blockade
(e. g. Anakinra, Rilonacept)
15. Vaccination with a live vaccine within 3 months before the baseline
16. Alcohol or drug abuse in the past 12 months
17. ≥400 ml donation of blood or loss up to 8 weeks before the baseline
18. Pregnancy or breast-feeding
19. Commitment of the patient to an institution at the direction of an authority or court
Locations and Contacts
Eugen Feist, PD Dr, Phone: +4930450513025, Email: eugen.feist@charite.de
Prof. Jörn Kekow, Vogelsang-Gommern 39245, Germany; Recruiting
Petra Alleinstein, Phone: +493920067319
Additional Information
Starting date: June 2012
Last updated: July 27, 2015
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