Anakinra in the treatment of acute calcium pyrophosphate arthritis
| ISRCTN | ISRCTN46471047 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46471047 |
| Secondary identifying numbers | 14-11 |
- Submission date
- 28/02/2011
- Registration date
- 18/03/2011
- Last edited
- 18/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alexander So
Scientific
Scientific
Service de Rhumatologie
Ave Pierre Decker 4
CHUV
Lausanne
1011
Switzerland
Study information
| Study design | Randomised double blind controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study acronym | APAC |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Anakinra |
| Primary outcome measure | 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 study start date | 01/05/2011 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 75 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Service de Rhumatologie
Lausanne
1011
Switzerland
1011
Switzerland
Sponsor information
University Hospital Centre and University of Lausanne (CHUV) (Switzerland)-Service of Rheumatology
Hospital/treatment centre
Hospital/treatment centre
Service de Rhumatologie
c/o Prof Alexander So
CHUV
Lausanne
1011
Switzerland
"ROR" |
https://ror.org/05a353079 |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospital Centre and University of Lausanne (CHUV) (Switzerland) -Research Fund of the Service of Rheumatology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
