Quality management: improvement of patient care in recently diagnosed rheumatoid arthritis
| ISRCTN | ISRCTN72821021 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72821021 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 17/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A C A Marijnissen
Scientific
Scientific
UMC Utrecht
Rheumatology & Clin. Immunology, F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 9758 |
|---|---|
| a.c.a.marijnissen@umcutrecht.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CAMERA |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure | 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 study start date | 01/01/1999 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 301 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
UMC Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Not defined
Not provided at time of registration
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/11/2007 | Yes | No |
