Differentiating the mechanism of action of anti-TNF alpha agents
| ISRCTN | ISRCTN44880063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44880063 |
| Secondary identifying numbers | 06/S0703/64 |
- 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
Not provided at time of registration
Contact information
Prof Iain McInnes
Scientific
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
| Study design | Randomised comparative parallel study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Differentiating the mechanism of action of anti-TNF alpha agents |
| Study 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(s) | West Glasgow Ethics Committee 1, 03/10/2006, ref: 06/S0703/74 |
| 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 |
| Primary outcome measure | 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 study start date | 19/03/2007 |
| Overall study end date | 19/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | Adults with established active rheumatoid or psoriatic arthritis. |
| 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
- Scotland
- United Kingdom
Study participating centre
Centre for Rheumatic Diseases
Glasgow
G31 2ER
United Kingdom
G31 2ER
United Kingdom
Sponsor information
NHS Greater Glasgow and Clyde/University of Glasgow (UK)
Government
Government
Centre for Rheumatic Diseases
University Tower Level 3
Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Government
NHS Greater Glasgow and Clyde R&D (ref: RN06RH005) (UK)
No information available
University of Glasgow (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| 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 |
Editorial Notes
18/04/2016: No publications found, verifying study status with principal investigator
