The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005450-20-BE

Enrollment

261

Registered

2009-10-01

Start date

2009-10-29

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Rheumatoid arthritis MedDRA version: 12.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis

Interventions

Trade Name: Remicade (infliximab) Pharmaceutical Form: Intravenous infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: remicade Concentration unit: mg/kg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Having been treated adequately with a primary ant TNF alpha agent and having failed due to ineffectiveness or the occurence of adverse events - Having moderate to high level of disease activity (DAS28>3.2) - No former treatment with abatacept or rituximab Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Contraindication for one of the study drugs - Having a strong preferance for one of the study druges

Design outcomes

Primary

Measure	Time frame
Main Objective: 1 year non-inferiority trial of abatacept vs rituximab vs a second anti-tnf alpha agent withe regards to mean DAS28 value measured at 6, 9 an 12 months;Secondary Objective: Cost-effectiveness analysis, drugsurvival, registration of daily practise use.;Primary end point(s): The primary endpoints will be the, for baseline DAS28 corrected, mean DAS28 score (clinical) measured at 6, 9 and 12 months, the EQ-5D score (overall 'quality of life' value) at 12 months and the direct and indirect costs from a societal perspective over a period of 12 months.	—

Measure

Time frame

Main Objective: 1 year non-inferiority trial of abatacept vs rituximab vs a second anti-tnf alpha agent withe regards to mean DAS28 value measured at 6, 9 an 12 months;Secondary Objective: Cost-effectiveness analysis, drugsurvival, registration of daily practise use.;Primary end point(s): The primary endpoints will be the, for baseline DAS28 corrected, mean DAS28 score (clinical) measured at 6, 9 and 12 months, the EQ-5D score (overall 'quality of life' value) at 12 months and the direct and indirect costs from a societal perspective over a period of 12 months.

—

Countries

Belgium

Outcome results

None listed

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