Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
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

UMC Utrecht
Rheumatology & Clin. Immunology
F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 9758
a.c.a.marijnissen@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CAMERA

Study hypothesis

It is possible to increase the efficacy of treatment in early Rheumatoid Arthritis (RA)-patients with Methotrexate (MTX) when treatment is intensified according to a strict and intensive, computer-assisted protocol, i.e. the number of patients in remission will increase.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

In this study the efficacy of two treatment strategies will be compared: intensive treatment versus conventional treatment with MTX. In both treatment strategy groups, patients will be treated with MTX. Starting dose MTX in both groups is 7.5 mg/wk.

In the intensive strategy group, based on predefined scores of disease activity with the help of a computer program, MTX will be increased to 15 mg/wk after 6 weeks. Thereafter, MTX is increased, if necessary, every 4 weeks by 5 mg/wk until a maximum dose of 30 mg/wk or until the maximum tolerable dose.

In the conventional treatment group, patients come to the outpatient clinic once every three months. In case of inefficient results of treatment after 3 months, dose MTX is increased until 15 mg/wk. After three months, dose MTX is increased by 5 mg/wk until a maximum of 30 mg/wk or maximum tolerable dose, if necessary.

In both groups folinic acid (0.5 mg/day) is prescribed to all patients.

To patients with gastrointestinal side effects or with insufficient efficacy, MTX is given subcutaneously. Treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) is allowed next to study medication. Oral glucocorticoids are not allowed during the trial unless unavoidable which has to be approved then by another rheumatologist. Intra-articular injections should be avoided as much as possible, and if necessary this should be mentioned.

Intervention type

Drug

Phase

Not Specified

Drug names

Methotrexate

Primary 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:
2.1. Number of swollen joints less than 3
2.2. Erythrocyte Sedimentation Rate (ESR) less than 20 mm/hr
2.3. Visual Analogue Scale (VAS) general well being less than 20 mm

Secondary outcome measures

1. Disease activity during 1 year
2. Feasibility of computer assisted program in daily practice

Overall trial start date

01/01/1999

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. RA, defined according to the revised American College of Rheumatology (ACR) criteria for RA
2. A disease duration of less than 1 year, estimated by the rheumatologist
3. Aged greater than 16 years
4. No previous treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs)
5. Written informed consent by the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

301

Participant exclusion criteria

1. Abnormal renal function (Cockroft less than 75 ml/min)
2. Abnormal liver function (Aspartate Aminotransferase [ASAT]/Alanine Aminotransferase [ALAT] greater than 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 conception, pregnancy, and/or breastfeeding
6. Chronic use of oral glucocorticoids
7. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study
8. Alcohol intake greater than 2 units per day or drug abuse, presently or in the past
9. Psychiatric or mental disorders which makes adherence to the study protocol impossible
10. Taking part into another clinical trial

Recruitment start date

01/01/1999

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

UMC Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17519278

Publication citations

  1. Results

    Verstappen SM, Jacobs JW, van der Veen MJ, Heurkens AH, Schenk Y, ter Borg EJ, Blaauw AA, Bijlsma JW, , Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial)., Ann. Rheum. Dis., 2007, 66, 11, 1443-1449, doi: 10.1136/ard.2007.071092.

Additional files

Editorial Notes