A randomised controlled study of combination therapy in rheumatoid arthritis (RA) patients with a suboptimal response to sulphasalazine
| ISRCTN | ISRCTN65477168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65477168 |
| Protocol serial number | C0640 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign (UK) |
- Submission date
- 10/07/2002
- Registration date
- 10/07/2002
- Last edited
- 02/10/2007
- 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 H Capell
Scientific
Scientific
Centre for Rheumatic Diseases
Glasgow Royal Infirmary
Castle Street
Glasgow
G4 0SF
United Kingdom
| Phone | +44 (0)141 211 4965 |
|---|---|
| hilary.capell@northglasgow.scot.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MASCOT |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Sulphasalazine will be used as a disease modifying agent for 6 months, target dose 40 mg/kg (to maximum tolerated dose or 4 g daily as maximum permitted dose). At 6 months those with a suboptimal response defined below will be randomly allocated to: 1. Sulphasalazine and methotrexate placebo 2. Sulphasalazine and active methotrexate 3. Active methotrexate and sulphasalazine placebo The maximum permitted dose of methotrexate will be 30 mg/week or methotrexate placebo. The maximum permitted dose of sulphasalazine will be 4 g/daily and no intra-articular or intramuscular steroid permitted within 1 month of the 6 month and 18 month assessments. All patients will receive weekly folic acid 5 mg daily between 6 and 18 months whether allocated to group 1, 2 or 3. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sulphasalazine, methotrexate, folic acid |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 29/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Male or female 2. Age 18 - 75 years 3. Onset of disease after age 16 4. Disease duration less than 5 years 5. Active inflammatory arthritis which is defined as six or more swollen joints plus two of the following: 5.1. Morning stiffness more than 45 minutes 5.2. Nine or more tender joints 5.3. Erythrocyte Sedimentation Rate (ESR) more than 28 mm/h |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/07/2002 |
| Date of final enrolment | 29/04/2005 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Centre for Rheumatic Diseases
Glasgow
G4 0SF
United Kingdom
G4 0SF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/02/2007 | Yes | No |
