Treatment in the Rotterdam Early Arthritis CoHort
| ISRCTN | ISRCTN26791028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26791028 |
| Secondary identifying numbers | NTR1019 |
- Submission date
- 23/08/2007
- Registration date
- 23/08/2007
- Last edited
- 21/10/2024
- 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
Not provided at time of registration
Contact information
Prof J.M.W. Hazes
Scientific
Scientific
Department of Rheumatology Ee965
Rotterdam
3000 WB
Netherlands
| Phone | +31 (0)10 703 4602 |
|---|---|
| j.hazes@erasmusmc.nl |
Study information
| Study design | Multicentre randomised single-centre parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.erasmusmc.nl/reumatologie/onderzoek/TREACH/ |
| Scientific title | Treatment in the Rotterdam Early Arthritis CoHort: a stratified, randomised clinical trial in patients with recent-onset arthritis |
| Study acronym | (T)REACH |
| Study hypothesis | In each stratum of probability there is a clinically and statistically significant difference in the functional ability and disease activity score over time (area under the curve) and progression of radiological joint damage after one year of follow-up in recent-onset arthritic patients who were having induction treatment with divergent intensity. |
| Ethics approval(s) | Medical Ethical Committee Erasmus University Rotterdam gave approval |
| Condition | Recent onset arthritis, rheumatoid arthritis |
| Intervention | Three monthly evaluations of disease activity score and safety. Medication adjustments by protocol, based on Disease Activity Score (DAS) calculations. If DAS is less than 2.4, medication will be switched to more intensive treatment including biologicals (initial biological will be etanersept). If DAS less than 1.6 is achieved for at least six months, patients will start to taper and finally stop all medication. Induction therapy for the three strata will be: 1. High probability (HP)-group: 1.1. Methotrexate (MTX) + Sulfasalazine (SSZ) + Hydroxychloroquine (HCQ) + one single dose corticosteroid intramuscular 1.2. MTX + SSZ + HCQ + prednisone 1.3. MTX + prednisone 2. Intermediate Probability (IP)-group: 2.1. MTX 2.2. HCQ 2.3. Prednisone 3. Low Probability (LP)-group: 3.1. Naproxen 3.2. HCQ 3.3. One single dose corticosteroids intramuscular |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methotrexate, sulfasalazine, hydroxychloroquine, prednisone, naproxen |
| Primary outcome measure | 1. Functional ability as measured by HAQ and DAS over time (area under the curve), assessed every 3 months 2. Progression of radiological joint damage as measured by Sharp/van der Heijde score, assessed every 6 months |
| Secondary outcome measures | 1. American College of Rheumatology (ACR) arthritis core-set, assessed every 3 months 2. Quality of Life, as measured with 36-item Short Form (SF-36), European Quality of Life scale (EuroQoL), assessed every 3 months 3. Costs |
| Overall study start date | 01/07/2007 |
| Overall study end date | 01/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 810 |
| Total final enrolment | 568 |
| Participant inclusion criteria | 1. Participant of the REACH cohort (patients with inflammatory joint complaints less then one year) 2. All patients must at least have one (out of 66) swollen joint Added 23/04/2009: 3. Aged 18 years or older, either sex |
| Participant exclusion criteria | 1. Definite diagnosis of crystal arthropathy, (post) infective arthritis or autoimmune rheumatic disorder 2. Previous therapy with disease modifying anti-rheumatic drugs (DMARDs) or corticosteroids 3. Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception 4. Concomitant treatment with an other experimental drug 5. History or presence of malignancy within the last five years 6. Elevated hepatic enzyme levels (aspartate aminotransferase [ASAT], alanine aminotransferase [ALAT] greater than two times normal value) 7. Thrombopoenia less than 150 x 10^9/l 8. Leucopoenia less than 3.0 x 10^9/l 9. Serum creatinine level greater than 150 umol/l |
| Recruitment start date | 01/07/2007 |
| Recruitment end date | 01/07/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 WB
Netherlands
3000 WB
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Rheumatology
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
Wyeth Pharmaceutical B.V. (Netherlands)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/06/2009 | Yes | No | |
| Results article | results | 01/10/2012 | Yes | No | |
| Results article | 1-year results | 01/07/2014 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No | |
| Results article | results on association between DNA methylation and methotrexate response | 26/06/2019 | 28/06/2019 | Yes | No |
| Results article | results | 01/09/2018 | 12/08/2019 | Yes | No |
| Results article | results on correlation between risk factors and clinical course | 23/01/2021 | 25/01/2021 | Yes | No |
| Results article | results on cost utility | 16/03/2021 | 17/03/2021 | Yes | No |
| Results article | results on DMARD-free remission | 05/08/2021 | 06/08/2021 | Yes | No |
| Results article | Combining patient-reported outcome measures to screen for active disease in rheumatoid arthritis and psoriatic arthritis | 18/10/2024 | 21/10/2024 | Yes | No |
Editorial Notes
21/10/2024: Publication reference added.
06/08/2021: Publication reference added.
17/03/2021: Publication reference added.
25/01/2021: Publication reference added.
12/08/2019: Publication reference and total final enrolment added.
28/06/2019: Publication reference added.
13/06/2016: Publication reference added.
On 23/04/2009 this record was updated; all amendments can be found under the relevant field. At this time, the overall trial end date was updated - the initial overall trial end date at the time of registration was 15/11/2007.
