Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study (NordicAOSD05)
Recruitment status was Active, not recruiting
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Purpose
An open, randomized, parallel-group, comparative, multicentre study. Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A or sulphasalazine. Patients enter the study if considered refractory to corticosteroids (prednisolone equivalent ≥10 mg/day) at the time of randomization.
The randomized phase of the study will be followed by an open-label extension (OLE) phase, to follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment with anakinra or one of the study DMARDs or a combination of study drugs for additional 28 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult-Onset Still's Disease |
Drug: anakinra |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open, Randomized Study Treating Refractory Adult-onset Still's Disease With Interleukin-1 Receptor Antagonist Anakinra (Kineret), Compared to an Established, Single Anti-rheumatic Drug Treatment |
- Number of patients reaching remission of the disease, after eight weeks of the randomized study treatment (Remission: afebrile and normalization of acute phase reactants) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Anakinra |
Drug: anakinra
100 mg subcutaneous injection daily
Other Name: Interleukin-1 receptor antagonist
|
Detailed Description:
Product: Kineret (anakinra) Comparative agents: Methotrexate or azathioprine or leflunomide or cyclosporin A or sulphasalazine Protocol title: An open, randomized study treating refractory adult-onset Still's disease with IL-1ra anakinra (Kineret, compared to an established, single anti-rheumatic treatment Target Disease: Adult-onset Still's disease Patients: 23 patients diagnosed with AOSD, living in the four Nordic countries.
Study Objectives: To follow the changes in clinical status and disease activity in patients receiving anakinra, compared to those treated with an established DMARD, in addition to corticosteroids in patients with refractory AOSD. To compare the changes in disease-related parameters (global health, patient's assessment on disease, laboratory values) in the two randomized groups. To assess the safety of anakinra in AOSD. To follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment in AOSD (open phase).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be diagnosed with AOSD according to preliminary classification by Yamaguchi (1992).
- Other diseases with similar symptoms must be excluded. Has been exposed to a corticosteroid for ≥2 months prior to randomization for AOSD.
- Needs a prednisolone dose ≥10 mg/day or equivalent, yet unacceptable disease activity determined by the investigator.
- Anti-TNF agents must be discontinued 4 to 8 weeks prior to commencing study medication.
Exclusion Criteria:
- Use of corticosteroids (prednisolone equivalent <10 mg/day.
History of recurrent or chronic infection, including:
- tuberculosis
- any malignancy
- any other major chronic inflammatory disease syndrome
- drug or alcohol abuse
- known positivity for hepatitis B, C or HIV.
- Use of anti-TNF agents during ≤4 weeks (etanercept) or≤8 weeks (infliximab or adalimumab) prior to randomization.
Contacts and Locations| Sweden | |
| Ann Kataja Knight | |
| Uppsala, Sweden, 75185 | |
| Principal Investigator: | Dan C Nordstrom, MD, PhD | Helsinki University Hospital, Department of Medicine |
More Information
No publications provided by Helsinki University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Can C Nordstrom, MD, PhD, Helsinki University, Faculty of Medicine, Helsinki, Finland |
| ClinicalTrials.gov Identifier: | NCT01033656 History of Changes |
| Other Study ID Numbers: | NordicAOSD05, 2005-003173-24 |
| Study First Received: | December 15, 2009 |
| Last Updated: | December 15, 2009 |
| Health Authority: | European Union: European Medicines Agency Finland: Finnish Medicines Agency |
Keywords provided by Helsinki University:
|
adult-onset Still's disease anakinra prednisolone disease-modifying antirheumatic drug |
methotrexate efficacy patients |
Additional relevant MeSH terms:
|
Still's Disease, Adult-Onset Arthritis, Juvenile Rheumatoid Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Antirheumatic Agents Interleukin 1 Receptor Antagonist Protein Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013