Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/10/2015
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 Simon Till

ORCID ID

Contact details

STH NHS Trust
Rheumatology
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0059111730

Study information

Scientific title

Randomised double blind trial of safety of anti-tumour necrosis factor (anti-TNF) chimeric monoclonal antibody (infliximab) in combination with methatrexate compared to methatrexate alone in patients with rheumatoid arthritis on standard disease modifying anti-rheumatic drugs

Acronym

Study hypothesis

Randomised double blind trial of safety of anti-tumour necrosis factor (TNF) chimeric monoclonal antibody (infliximab) in combination with methatrexate compared to methatrexate alone in patients with rheumatoid arthritis on standard disease modifying anti-rheumatic drugs

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Musculoskeletal Diseases: Rheumatoid arthritis (RA)

Intervention

Infliximab in combination with methatrexate compared to methatrexate alone.

Intervention type

Drug

Phase

Not Applicable

Drug names

Anti-tumour necrosis factor (TNF), chimeric monoclonal antibody (infliximab), methatrexate

Primary outcome measures

Currently unavailable.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2001

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with rheumatoid arthritis on standard disease modifying anti-rheumatic drugs (DMARD)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/12/2001

Recruitment end date

01/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Trust
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Sheffield Teaching Hospitals NHS Foundation Trust (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

Publication citations

Additional files

Editorial Notes