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| Differentiating the mechanism of action of anti-TNF alpha agents |
| Source of record | UK Trials |
| ISRCTN | ISRCTN44880063 |
| Date ISRCTN assigned | 10/01/2008 |
| Local reference number(s) | 06/S0703/64 |
| Public title | Differentiating the mechanism of action of anti-TNF alpha agents |
| Scientific title | |
| Acronym | DATA study |
| Disease/condition/study domain | Rheumatoid arthritis |
| Study hypothesis | Effect of two different anti-TNF inhibitors on mRNA and cytokine protein expression in rheumatoid arthritis and psoriatic arthritis. |
| Design/methodology | Randomised, comparative, parallel study. |
| Research ethics review | West Glasgow Ethics Committee 1, approved on 3 October 2006 (ref: 06/S0703/74) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Adults with established active rheumatoid or psoriatic arthritis. |
| Participants - exclusion criteria | Prinicipal exclusion criteria in accord with clinical use of anti-TNF inhibitors. |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 19/03/2007 |
| Anticipated end date | 19/03/2009 |
| Status of trial | Ongoing |
| Target number of participants | 40 |
| Interventions | 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 |
| 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 |
| 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 |
| Sources of funding | 1. NHS Greater Glasgow and Clyde R&D (ref: RN06RH005) (UK) 2. University of Glasgow (UK) |
| Sponsor name | 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 United Kingdom G31 2ER |
| Contact name | Prof Iain McInnes |
| Contact details | Centre for Rheumatic Diseases University Tower Level 3 Queen Elizabeth Building Glasgow Royal Infirmary 10 Alexandra Parade Glasgow United Kingdom G31 2ER |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN44880063 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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