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Canakinumab for Treatment of Adult Onset Still's Disease (CONSIDER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204293
Recruitment Status : Terminated (Recruitment issues due to marketing authorization of study drug)
First Posted : July 30, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Eugen Feist, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Adult-Onset Still´s Disease Drug: Canakinumab Drug: Placebo Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Canakinumab for Treatment of Adult Onset Still's Disease to Achieve Reduction of Arthritic Manifestation
Actual Study Start Date : June 21, 2012
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : May 5, 2018


Arm Intervention/treatment
Placebo Comparator: Placebo Injections
Placebo injections will be administered subcutaneously every 4 weeks.
Drug: Placebo Injection
Placebo will be injected subcutaneously every 4 weeks
Other Name: Placebo

Active Comparator: Canakinumab
Canakinumab sc 4mg/kg BW up to 300mg every 4 weeks
Drug: Canakinumab
Canakinumab will be injected subcutaneously in a dose of 4mg/kg body weight up to a maximum of 300 mg every 4 weeks.
Other Name: Ilaris

Drug: Canakinumab
For responders on week 24 possibility of open-label treatment with Canakinumab sc every 4 weeks for further 2 years. There will be the possibility to make a downtitration, according to specific criteria.
Other Name: Ilaris




Primary Outcome Measures :
  1. Efficacy of canakinumab with a clinically-significant reduction in disease activity [ Time Frame: 12 weeks ]
    Investigation of the efficacy of canakinumab in patients with AOSD and active joint involvement in terms of the proportion of patients with a clinically-significant reduction in disease activity (DAS28 > 1.2) following a treatment period of 12 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204293


Locations
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Germany
Charité Campus Mitte
Berlin, Germany, 10117
Immanuel Krankenhaus Berlin
Berlin, Germany, 13125
Universität Erlangen
Erlangen, Germany, 91054
Kliniken Essen-Süd/Krankenhaus St. Josef
Essen, Germany, 45239
Universitätsklinikum der J.W. Goethe-Universität Frankfurt
Frankfurt a. M., Germany, 60590
Asklepios Klinikum Hamburg Altona
Hamburg, Germany, 22763
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätskrankenhaus Schleswig Holstein
Kiel, Germany, 24105
Med. Klinik I für Innere Medizin Köln
Köln, Germany, 50937
Klinikum der Universität München
München, Germany, 80336
Klinikum Südstadt Rostock
Rostock, Germany, 18059
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Fachkrankenhaus
Vogelsang, Germany, 39245
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Eugen Feist, Prof. Dr. Charité University Berlin Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eugen Feist, PD Dr Eugen Feist, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02204293    
Other Study ID Numbers: CACZ885GDE01T
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Keywords provided by Eugen Feist, Charite University, Berlin, Germany:
Adult-Onset Still´s Disease
Canakinumab
Joint involvement
AOSD
Additional relevant MeSH terms:
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Arthritis, Juvenile
Still's Disease, Adult-Onset
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs