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
Secondary identifying numbers	C0640

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr H Capell
Scientific

Centre for Rheumatic Diseases
Glasgow Royal Infirmary
Castle Street
Glasgow
G4 0SF
United Kingdom

Phone	+44 (0)141 211 4965
Email	hilary.capell@northglasgow.scot.nhs.uk

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	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sulphasalazine, methotrexate, folic acid
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	31/07/2002
Completion date	29/04/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

Centre for Rheumatic Diseases

Glasgow
G4 0SF
United Kingdom

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Charity

Arthritis Research Campaign (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/02/2007		Yes	No