Condition category
Musculoskeletal Diseases
Date applied
10/07/2002
Date assigned
10/07/2002
Last edited
02/10/2007
Prospective/Retrospective
Prospectively 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 H Capell

ORCID ID

Contact details

Centre for Rheumatic Diseases
Glasgow Royal Infirmary
Castle Street
Glasgow
G4 0SF
United Kingdom
+44 (0)141 211 4965
hilary.capell@northglasgow.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C0640

Study information

Scientific title

Acronym

MASCOT

Study hypothesis

Not provided at time of registration

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

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 names

Sulphasalazine, methotrexate, folic acid

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/07/2002

Overall trial end date

29/04/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/07/2002

Recruitment end date

29/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Rheumatic Diseases
Glasgow
G4 0SF
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK)

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=16926184

Publication citations

  1. Results

    Capell HA, Madhok R, Porter DR, Munro RA, McInnes IB, Hunter JA, Steven M, Zoma A, Morrison E, Sambrook M, Wui Poon F, Hampson R, McDonald F, Tierney A, Henderson N, Ford I, Combination therapy with sulfasalazine and methotrexate is more effective than either drug alone in patients with rheumatoid arthritis with a suboptimal response to sulfasalazine: results from the double-blind placebo-controlled MASCOT study., Ann. Rheum. Dis., 2007, 66, 2, 235-241, doi: 10.1136/ard.2006.057133.

Additional files

Editorial Notes