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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37438295 |
| EudraCT/CTIS number | 2007-001190-28 |
| Secondary identifying numbers | HTA 06/303/84; KCL (Rheum) TACIT Version 1 (26/01/07) |
- Submission date
- 11/06/2007
- Registration date
- 12/06/2007
- Last edited
- 29/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.medscinet.net/TACIT/patientinfodocs/Summary%20PIS%20Version%201%20%2820.12.07%29.pdf
Contact information
Prof David L Scott
Scientific
Scientific
Department of Academic Rheumatology
King's College London
Weston Education Centre
Cutcombe Road
Denmark Hill
London
SE5 9RJ
United Kingdom
| Phone | +44 (0)20 7848 5215 |
|---|---|
| david.l.scott@kcl.ac.uk |
Study information
| Study design | Two-arm pragmatic 12-month randomised controlled multi-centred trial using open-label treatments |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.medscinet.net/tacit/patientinfo.aspx?id=1 |
| Scientific title | Randomised controlled trial of Tumour necrosis factor inhibitors Against Combination Intensive Therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis |
| Study acronym | TACIT |
| Study objectives | 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. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0630384 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/51339/PRO-06-303-84.pdf |
| Ethics approval(s) | Research ethics committee of the UCLH A, 20/04/2007, ref: 07/Q0505/57 |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Adalimumab, etanercept, infliximab, methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, ciclosporin and gold injections (sodium aurothiomalate) |
| Primary outcome measure | Heath Assessment Questionnaire (HAQ). Primary and secondary outcomes will be measured at baseline (month 0), 6 months and 12 months. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/04/2007 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 190 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
London
SE5 9RJ
United Kingdom
SE5 9RJ
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Strand
London
WC2R 2LS
England
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| ceu@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2014 | Yes | No | |
| Results article | results | 13/03/2015 | Yes | No | |
| Other publications | secondary analysis | 26/08/2016 | Yes | No | |
| Results article | cost-effectiveness results | 01/03/2020 | 13/07/2020 | Yes | No |
| Results article | Characterization of missing data patterns and mechanisms | 17/09/2022 | 29/09/2022 | Yes | No |
Editorial Notes
29/09/2022: Publication reference added.
13/07/2020: Publication reference added.
22/09/2016: Publication reference added.
