Condition category
Musculoskeletal Diseases
Date applied
22/02/2007
Date assigned
10/01/2008
Last edited
18/04/2016
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

Prof Iain McInnes

ORCID ID

Contact details

Centre for Rheumatic Diseases
University Tower Level 3
Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/S0703/64

Study information

Scientific title

Differentiating the mechanism of action of anti-TNF alpha agents

Acronym

DATA study

Study hypothesis

Effect of two different anti-TNF inhibitors on mRNA and cytokine protein expression in rheumatoid arthritis and psoriatic arthritis.

Ethics approval

West Glasgow Ethics Committee 1, 03/10/2006, ref: 06/S0703/74

Study design

Randomised comparative parallel study.

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

Rheumatoid arthritis

Intervention

Comparing two different anti TNF drugs:
1. Infliximab 3 mg/kg at week 0, 2, 6 and thereafter every 8 weeks administered intravenously for 12 months
2. Etanercept 25 mg twice weekly administered subcutaneously for 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Effect of the two different anti-TNF inhibitors on mRNA and cytokine protein expression in rheumatoid arthritis and psoriatic arthritis:
1. mRNA, measured at week 0, 4, and 12
2. Cytokines, measured at week 0, 4, and 12

Secondary outcome measures

Effect on clinical and physiological measures and their correlation with changes in mRNA and cytokine expression. The clinical and physiological measures include the following:
1. Synovial biopsy at baseline (week 0) and week 4
2. Skin biopsy at baseline (week 0) and week 4
3. Ultrasound at baseline and 1 month
4. Hypoxia measurements at baseline and 1 month
5. Blood tests:
5.1. Erythrocyte Sedimentation Rate (ESR), measured monthly for the duration of the study (1 year)
5.2. C-Reactive Protein (CRP), measured monthly for the duration of the study (1 year)
5.3. Anti-Cyclic Citrullinated Peptide (anti-CCP) antibody at screening visit
5.4. Rheumatoid factor at screening visit
5.5. Full Blood Count (FBC), measured monthly for the duration of the study (1 year)
5.6. Urea and Electrolytes (U&E's), measured monthly for the duration of the study (1 year)
5.7. Liver Function Tests (LFT's), measured monthly for the duration of the study (1 year)
5.8. Hepatitis B and C at screening visit

Overall trial start date

19/03/2007

Overall trial end date

19/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with established active rheumatoid or psoriatic arthritis.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Prinicipal exclusion criteria in accord with clinical use of anti-TNF inhibitors.

Recruitment start date

19/03/2007

Recruitment end date

19/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Rheumatic Diseases
Glasgow
G31 2ER
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde/University of Glasgow (UK)

Sponsor details

Centre for Rheumatic Diseases
University Tower Level 3
Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

NHS Greater Glasgow and Clyde R&D (ref: RN06RH005) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Glasgow (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

18/04/2016: No publications found, verifying study status with principal investigator