Condition category
Musculoskeletal Diseases
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
13/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J.M.W. Hazes

ORCID ID

Contact details

Department of Rheumatology Ee965
Rotterdam
3000 WB
Netherlands
+31 (0)10 703 4602
j.hazes@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR1019

Study information

Scientific title

Treatment in the Rotterdam Early Arthritis CoHort: a stratified, randomised clinical trial in patients with recent-onset arthritis

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

Medical Ethical Committee Erasmus University Rotterdam gave approval

Study design

Multicentre randomised single-centre parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at: http://www.erasmusmc.nl/reumatologie/onderzoek/TREACH/

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

Phase

Not Applicable

Drug names

Methotrexate, sulfasalazine, hydroxychloroquine, prednisone, naproxen

Primary outcome measures

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 trial start date

01/07/2007

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

810

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

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 WB
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Department of Rheumatology
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Industry

Funder name

Wyeth Pharmaceutical B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19538718
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22673898
2014 1-year results in: http://www.ncbi.nlm.nih.gov/pubmed/24788619
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27283332

Publication citations

  1. Protocol

    Claessen SJ, Hazes JM, Huisman MA, van Zeben D, Luime JJ, Weel AE, Use of risk stratification to target therapies in patients with recent onset arthritis; design of a prospective randomized multicenter controlled trial., BMC Musculoskelet Disord, 2009, 10, 71, doi: 10.1186/1471-2474-10-71.

  2. Results

    de Jong PH, Weel AE, de Man YA, Huisman AM, Gerards AH, van Krugten MV, Luime JJ, Hazes JM, Brief Report: to squeeze or not to squeeze, that is the question! Optimizing the disease activity score in 28 joints by adding the squeeze test of metatarsophalangeal joints in early rheumatoid arthritis., Arthritis Rheum., 2012, 64, 10, 3095-3101, doi: 10.1002/art.34568.

  3. de Jong PH, Hazes JM, Han HK, Huisman M, van Zeben D, van der Lubbe PA, Gerards AH, van Schaeybroeck B, de Sonnaville PB, van Krugten MV, Luime JJ, Weel AE, Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial., Ann. Rheum. Dis., 2014, 73, 7, 1331-1339, doi: 10.1136/annrheumdis-2013-204788.

  4. Results

    Kuijper TM, Luime JJ, de Jong PH, Gerards AH, van Zeben D, Tchetverikov I, de Sonnaville PB, van Krugten MV, Grillet BA, Hazes JM, Weel AE, Tapering conventional synthetic DMARDs in patients with early arthritis in sustained remission: 2-year follow-up of the tREACH trial, Ann Rheum Dis, 2016 , annrheumdis-2016-209272, doi: 10.1136/annrheumdis-2016-209272.

Additional files

Editorial Notes

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.