Triple therapy in early active rheumatoid arthritis - TEAR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002006-30-GB

Enrollment

Registered

2005-02-17

Start date

2004-11-17

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Product Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 25- Trade Name: Salazopyri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis Active disease (measured using the validated disease activity score) Disease duration =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous use of disease modifying drugs (other than hydroxychloroquine) AST >80 ALP > 700 Creatinine > 160 White cell count <4 Platelet count < 150 Pregnancy, planned pregnancy, unwillingness to use contraception

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the trial is to test the hypothesis that improved, sustained disease contol (with acceptable toxicity) will result from early triple therapy with methotrexate, hydroxychloroquine and sulfasalazine. The specific research questions that will be addressed are: 1) Does early triple therapy in the treatment of early active rheumatoid arthritis confer significant benfits in terms of disease control when compared to a 'step up' strategy for the use of disease odifying drug therapy?;Secondary Objective: 2) Does early triple therapy in the treatment of early active rheumatoid arthritis result in improved physical function, quality of life and reduced radiological damage? 3) Is there excess toxicity associated with the use of early triple therapy?;Primary end point(s): Mean change in disease activity score (DAS28) Proportion of patients with a 'good response' (EULAR definition)	—

Measure

Time frame

Main Objective: The aim of the trial is to test the hypothesis that improved, sustained disease contol (with acceptable toxicity) will result from early triple therapy with methotrexate, hydroxychloroquine and sulfasalazine. The specific research questions that will be addressed are: 1) Does early triple therapy in the treatment of early active rheumatoid arthritis confer significant benfits in terms of disease control when compared to a 'step up' strategy for the use of disease odifying drug therapy?;Secondary Objective: 2) Does early triple therapy in the treatment of early active rheumatoid arthritis result in improved physical function, quality of life and reduced radiological damage? 3) Is there excess toxicity associated with the use of early triple therapy?;Primary end point(s): Mean change in disease activity score (DAS28) Proportion of patients with a 'good response' (EULAR definition)

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026