TApering strategies in Rheumatoid Arthritis remission induced by anti-TNF&classic DMARDs. Should we taper the classic DMARD or anti-TNF first?

TApering strategies in Rheumatoid Arthritis remission induced by anti-TNF&classic DMARDs. Should we taper the classic DMARD or anti-TNF first? - TARA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41388

Enrollment

355

Registered

2011-05-11

Start date

2011-06-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

rheumatism rheumatoid arthritis

Interventions

The aim of treatment is to maintain low disease activity as expressed by the Disease Activity Score (DAS)2.4 or swollen joint count > 1. I

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: RA patients, aged >17 years, treated with DMARDs&etanercept,adalimumab,certolizumab or golimumab, DAS

Exclusion criteria

Exclusion criteria: Not being able to understand, speak and write in Dutch. Being diagnosed with a psychiatric or personality disorder.

Design outcomes

Primary

Measure	Time frame
Primary outcome clinical effectiveness: Disease flare defined as DAS44>2.4 or swollen joint count>1 during the first year of the study. Primary outcome cost-effectiveness: Incremental Cost Effectiveness Ratio (ICER) of tapering DMARDs versus tapering anti-TNF in terms of cost per QALY gained and in terms of cost per tapered patient.	—

Secondary

Measure	Time frame
Secondary outcomes will include the number of disease flares during the second year of the study, radiographic progression at 1 and 2 years, presence of ultrasonographic synovitis and erosions over the first 12 months, the HAQ, the SF36, sick leave, productivity loss at work and cost-effectiveness modelled over the long term. Informed patient preferences about tapering strategies in anti-TNF&MTX users will be obtained in a subgroup of (potential) study candidates using discrete choice experiments. Outcomes blood research: - serum concentrations of adalimumab/etanercept, methotrexate (methotrexate polyglutamate in erythrocytes) and anti-drug antibodies. - the ratio between Th-17-lymfocytes and other T-lymfocytes at baseline, flare (DAS44>2.4 or SJC>1) and 3 months after the occurence of a flare. - the pathogenecity of Th17-lymfocytes at baseline, flare (DAS44>2.4 or SJC>1) and 3 months after the occurence of a flare.	—

Measure

Time frame

Secondary outcomes will include the number of disease flares during the second year of the study, radiographic progression at 1 and 2 years, presence of ultrasonographic synovitis and erosions over the first 12 months, the HAQ, the SF36, sick leave, productivity loss at work and cost-effectiveness modelled over the long term. Informed patient preferences about tapering strategies in anti-TNF&MTX users will be obtained in a subgroup of (potential) study candidates using discrete choice experiments. Outcomes blood research: - serum concentrations of adalimumab/etanercept, methotrexate (methotrexate polyglutamate in erythrocytes) and anti-drug antibodies. - the ratio between Th-17-lymfocytes and other T-lymfocytes at baseline, flare (DAS44>2.4 or SJC>1) and 3 months after the occurence of a flare. - the pathogenecity of Th17-lymfocytes at baseline, flare (DAS44>2.4 or SJC>1) and 3 months after the occurence of a flare.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)