|
Welcome
|
|
19 November 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Randomised controlled trial of Tumour necrosis factor inhibitors Against Combination Intensive Therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis |
| ISRCTN | ISRCTN37438295 |
| ClinicalTrials.gov identifier | |
| 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 |
| Serial number at source | HTA 06/303/84; KCL (Rheum) TACIT Version 1 (26/01/07) |
| 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. |
| Ethics approval | Received from the research ethics committee of the UCLH A on the 20th April 2007 (ref: 07/Q0505/57). |
| Study design | Two arm pragmatic 12 month randomised controlled multi-centred trial using open-label treatments |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Rheumatoid Arthritis |
| 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) |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| 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) |
| Trial website | |
| Publications | |
| Contact name | Prof David L Scott |
| Address |
Department of Academic Rheumatology
King's College London Weston Education Centre Cutcombe Road Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 9RJ |
| Country | United Kingdom |
| Tel | +44 (0)20 7848 5215 |
| Fax | +44 (0)20 7848 5202 |
| david.l.scott@kcl.ac.uk | |
| Sponsor | King's College London (UK) |
| Address | Strand |
| City/town | London |
| Zip/Postcode | WC2R 2LS |
| Country | United Kingdom |
| Tel | +44 (0)20 7836 5454 |
| ceu@kcl.ac.uk | |
| Sponsor website: | http://www.kcl.ac.uk |
| Date applied | 11/06/2007 |
| Last edited | 29/01/2008 |
| Date ISRCTN assigned | 12/06/2007 |
|
|
|
| © ISRCTN | |
|
|
|
|