Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14-11
Study information
Scientific title
A multicentre, randomised, controlled, double-blind study, evaluating the efficacy and safety of anakinra in chondrocalcinosis (Étude multicentrique randomisée contrôlée en double-aveugle contre placebo, évaluant lefficacité et la sécurité de lanakinra dans la crise de chondrocalcinose articulaire)
Acronym
APAC
Study hypothesis
To demonstrate that 3 x daily injections of anakinra is effective in treatment of acute symptoms of calcium pyrophosphate arthritis in comparison with an active comparator, prednisolone 30mg daily for 3 days
Ethics approval
Cantonal ethics committee for research on human (Commission cantonale d'éthique de la recherche sur l'être humain"), the date of approval 20/2/2011, reference no: 14/11
Study design
Randomised double blind controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chondrocalcinosis
Intervention
3 x daily injection of anakinra 100mg versus 3 x daily oral intake of prednisolone 30mg.
The primary end point is at day 7 and the study will run over a total of 28 days.
Intervention type
Drug
Phase
Not Specified
Drug names
Anakinra
Primary outcome measures
Visual Analogue Scale (VAS) pain score of arthritis in the target joint at 72h
Secondary outcome measures
1. Effect of therapy on pain and symptoms of arthritis up to day 28 using a VAS and Likert scales for pain and patient and physician assessment of signs and symptoms of inflammation
2. Tolerance and side effects of the treatments will be assessed by the investigators
Overall trial start date
01/05/2011
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Informed consent
2. Male or female from 18-99 years of age
3. Diagnosis of acute calcium pyrophosphate arthritis based on symptoms of acute arthritis and presence of crystals of chronic calcium pyrophosphate dihydrate (CPPD) in the synovial liquid at screening or from a prior analysis
4. The start of the acute arthritis should be less than 5 days from inclusion in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75
Participant exclusion criteria
1. Corticotherapy orally with dose equivalent of prednisone > 10mg during the 24 h preceding inclusion
2. Corticotherapy intramuscular (im) or intravenous (iv) during the 72h preceding inclusion, no matter the dose
3. Corticotherapy intra-articularly during 7 days preceding inclusion
4. Chronic oral corticotherapy of > 10mg daily
5. Uncontrolled respiratory or cardiac failure
6. Other causes of acute arthritis
7. Active gastric or duodenal ulceration
8. Untreated and active malignancy
9. Known intolerance or allergy to the study medications
10. Active and untreated infection assessed by investigator as a contraindication to study medications
11. Other medical problems that are judged prejudicial to the inclusion of the patient in the study by the investigator
12. Pregancy or active breast feeding
Recruitment start date
01/05/2011
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Switzerland
Trial participating centre
Service de Rhumatologie
Lausanne
1011
Switzerland
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Centre and University of Lausanne (CHUV) (Switzerland) -Research Fund of the Service of Rheumatology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary