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| Randomised controlled trial of Tumour necrosis factor inhibitors Against Combination Intensive Therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN37438295 |
| Date ISRCTN assigned | 12/06/2007 |
| Local reference number(s) | HTA 06/303/84; KCL (Rheum) TACIT Version 1 (26/01/07) |
| Public title | Randomised controlled trial of Tumour necrosis factor inhibitors Against Combination Intensive Therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis |
| Scientific title | |
| Acronym | TACIT |
| Disease/condition/study domain | Rheumatoid Arthritis |
| Study hypothesis | Active Rheumatoid Arthritis (RA) patients, who meet the National Institute for Clinical Excellence (NICE) criteria for treatment with Tumour Necrosis Factor (TNF) inhibitors, will gain equivalent benefit from intensive combination therapy (two or more Disease Modifying Anti-Rheumatic Drugs [DMARDs] and steroids) at substantially less expense and without increased toxicity. |
| Design/methodology | Two arm pragmatic 12 month randomised controlled multi-centred trial using open-label treatments |
| Research ethics review | Received from the research ethics committee of the UCLH A on the 20th April 2007 (ref: 07/Q0505/57). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Males and Females aged over 18 years 2. Established RA by the criteria of the American College of Rheumatology 3. Disease duration of at least 12 months 4. Meet NICE criteria for being prescribed TNF inhibitors: 4.1. Disease Activity Score (DAS) over 5.1 4.2. Failure to respond to two DMARDs including methotrexate 4.3. No contra-indications to TNF inhibitors (including possibility of pregnancy) |
| Participants - exclusion criteria | 1. Unable or unwilling to give informed consent 2. Failure of, or contra-indications to, all proposed DMARD combinations (including possibility of pregnancy) 3. Serious inter-current illness 4. Patients on high dose steroids (in excess of 10 mg prednisolone or equivalent per day at trial entry) |
| Patient information material | |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Ongoing |
| Target number of participants | 190 |
| Interventions | There will be two treatment algorithms: 1. For TNF inhibitors, and 2. For combination DMARDs Treatments will be individualised and will depend on patients' responses. TNF inhibitors: All three licensed agents - adalimumab, etanercept, and infliximab - will be allowed at standard doses (British National Formulary). The choice of TNF inhibitor will reflect patient's preferences and local circumstances. Methotrexate will also be given to maximise efficacy and (in the case of infliximab) reduce anti-chimeric antibodies. Any patient intolerant to methotrexate may take another DMARD. Combination DMARDs: DMARDs from the following list will be used: methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, ciclosporin and gold injections (sodium aurothiomalate) in combinations with proven efficacy over DMARD monotherapy in Randomised Controlled trials (RCTs). For example: 1. Triple therapy with methotrexate (methotrexate-sulfasalazine-hydroxychloroquine) 2. Other methotrexate combinations (methotrexate-ciclosporin, methotrexate-leflunomide and methotrexate-gold) 3. One sulfasalazine combination (sulfasalazine-leflunomide) Additional monthly steroids (intramuscular [IM] depomedrone [120 mg stat] or equivalent) will also be used if needed. The duration of treatment is one year and patients are followed for only this year. |
| Primary outcome measure(s) | Heath Assessment Questionnaire (HAQ). Primary and secondary outcomes will be measured at baseline (month 0), 6 months and 12 months. |
| Secondary outcome measure(s) | 1. Joint damage 2. Quality of life 3. Disease activity 4. Withdrawal rates 5. Adverse effects 6. Economic evaluation: 6.1. Societal costs 6.2. Cost-effectiveness 6.3. Cost-utility Primary and secondary outcomes will be measured at baseline (month 0), 6 months and 12 months. Patients will be asked to attend monthly for blood monitoring and will be asked a short questionnaire regarding concomitant medication, any tests outside routine monitoring and adverse events within the last month. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | King's College London (UK) |
| Sponsor details | Strand London United Kingdom WC2R 2LS |
| Sponsor telephone | +44 (0)20 7836 5454 |
| Sponsor email | ceu@kcl.ac.uk |
| Sponsor website | http://www.kcl.ac.uk |
| Contact name | Prof David L Scott |
| Contact details | Department of Academic Rheumatology King's College London Weston Education Centre Cutcombe Road Denmark Hill London United Kingdom SE5 9RJ |
| Contact telephone | +44 (0)20 7848 5215 |
| Contact fax | +44 (0)20 7848 5202 |
| Contact email | david.l.scott@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN37438295 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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