Condition category
Musculoskeletal Diseases
Date applied
28/02/2011
Date assigned
18/03/2011
Last edited
18/03/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexander So

ORCID ID

Contact details

Service de Rhumatologie
Ave Pierre Decker 4
CHUV
Lausanne
1011
Switzerland

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 l’efficacité et la sécurité de l’anakinra 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

Sponsor information

Organisation

University Hospital Centre and University of Lausanne (CHUV) (Switzerland)-Service of Rheumatology

Sponsor details

Service de Rhumatologie
c/o Prof Alexander So
CHUV
Lausanne
1011
Switzerland

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes