Condition category
Musculoskeletal Diseases
Date applied
28/03/2006
Date assigned
29/03/2006
Last edited
21/03/2013
Prospective/Retrospective
Retrospectively 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 A.C.A. Marijnissen

ORCID ID

Contact details

University Medical Center Utrecht (UMCU)
Department of Rheumatology and Clinical Immunology
F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509758
a.c.a.marijnissen@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CAMERA-II

Study hypothesis

Prednisone inhibits progression of joint damage in early RA-patients, even when intensive treatment, according to a strict computer-assisted protocol, is applied.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis (RA)

Intervention

10 mg of prednisolone daily versus placebo in addition to DMARDs. Two year study.

Intervention type

Drug

Phase

Not Applicable

Drug names

Prednisone and DMARDs

Primary outcome measures

Radiologic joint damage of hands and feet according to the van der Heijde modification of the Sharp scoring method.

Secondary outcome measures

Number of patients in remission, in which remission is defined as:
1. Number of swollen joints = 0
2. Plus at least two out of three following criteria:
2.a. Number of swollen joints <3
2.b. Erythrocyte sedimentation rate (ESR) <20 mm/1st hour
2.c. Visual analogue scale (VAS) of general well being <20 mm

Overall trial start date

01/04/2003

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Rheumatoid Arthritis, defined according to the revised American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
2. A disease duration of less than 1 year, estimated by the rheumatologist
3. Age >18 years
4. No previous treatment with DMARDs or oral glucocorticoids
5. Written informed consent by the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Abnormal renal function (Cockroft <75 ml/min)
2. Abnormal liver function (aspartate aminotransferase [ASAT]/alanine aminotransferase [ALAT] >2 x normal), active or recent hepatitis, cirrhosis
3. Major co-morbidities like malignancies, severe diabetic mellitus, severe infections, severe cardio and/or respiratory diseases
4. Leukopenia and/or thrombocytopenia
5. Inadequate birth control contraception, pregnancy, and/or breastfeeding
6. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study
7. Alcohol intake >2 units per day or drug abuse, presently or in the past
8. Psychiatric or mental disorders which makes adherence to the study protocol impossible
9. Taking part in another clinical trial
10. Osteoporotic vertebral fractures

Recruitment start date

01/04/2003

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

University Medical Center Utrecht (UMCU), Abbott

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22393128
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22807253

Publication citations

  1. Results

    Bakker MF, Jacobs JW, Welsing PM, Verstappen SM, Tekstra J, Ton E, Geurts MA, van der Werf JH, van Albada-Kuipers GA, Jahangier-de Veen ZN, van der Veen MJ, Verhoef CM, Lafeber FP, Bijlsma JW, , Low-dose prednisone inclusion in a methotrexate-based, tight control strategy for early rheumatoid arthritis: a randomized trial., Ann. Intern. Med., 2012, 156, 5, 329-339, doi: 10.7326/0003-4819-156-5-201203060-00004.

  2. Results

    Jurgens MS, Jacobs JW, Geenen R, Bossema ER, Bakker MF, Bijlsma JW, van Albada-Kuipers IA, Ehrlich JC, Lafeber FP, Welsing PM, , Increase of body mass index in a tight controlled methotrexate-based strategy with prednisone in early rheumatoid arthritis: side effect of the prednisone or better control of disease activity?, Arthritis Care Res (Hoboken), 2013, 65, 1, 88-93, doi: 10.1002/acr.21797.

Additional files

Editorial Notes