Differentiating the mechanism of action of anti-TNF alpha agents

ISRCTN	ISRCTN44880063
DOI	https://doi.org/10.1186/ISRCTN44880063
Protocol serial number	06/S0703/64
Sponsor	NHS Greater Glasgow and Clyde/University of Glasgow (UK)
Funders	NHS Greater Glasgow and Clyde R&D (ref: RN06RH005) (UK), University of Glasgow (UK)

Submission date: 22/02/2007
Registration date: 10/01/2008
Last edited: 18/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Iain McInnes
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised comparative parallel study.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Differentiating the mechanism of action of anti-TNF alpha agents
Study acronym	DATA study
Study objectives	Effect of two different anti-TNF inhibitors on mRNA and cytokine protein expression in rheumatoid arthritis and psoriatic arthritis.
Ethics approval(s)	West Glasgow Ethics Committee 1, 03/10/2006, ref: 06/S0703/74
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	19/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	Adults with established active rheumatoid or psoriatic arthritis.
Key exclusion criteria	Prinicipal exclusion criteria in accord with clinical use of anti-TNF inhibitors.
Date of first enrolment	19/03/2007
Date of final enrolment	19/03/2009

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Centre for Rheumatic Diseases

Glasgow
G31 2ER
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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