U-Act-After: An Observational Study on Long-Term Efficacy of Tight Control RoActemra/Actemra (Tocilizumab) and/or Methotrexate in Patients With Early Rheumatoid Arthritis Who Have Participated in the U-Act-Early Study (ML22497)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01918267

Enrollment

226

Registered

2013-08-07

Start date

2012-04-10

Completion date

2017-10-10

Last updated

2018-05-11

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

Conditions

Rheumatoid Arthritis

Brief summary

This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must have participated in the U-Act-Early trial (ML22497); these are adult patients (\> 20 years of age) with rheumatoid arthritis. * Patients must be willing to give written informed consent

Exclusion criteria

* Patients who did not participate in the U-Act-Early trial * Patients who are drop-outs in the U-Act-Early trial due to withdrawal of consent, are lost to follow-up or are serious protocol violators

Design outcomes

Primary

Measure	Time frame
Change in Disease Activity Score (DAS28)	from baseline to Month 36

Secondary

Measure	Time frame
Measure of progressive joint destruction (vdHSS)	from baseline of U-Act-Early to Month 24 of U-Act-After
Changes in concomitant medication (especially tapering of corticosteroids)	from baseline to Months 36
Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)	from baseline to Month 36
Dose modifications/interruptions of RA treatment	36 months
Safety: Incidence of adverse events, adverse events of special interest and serious adverse events	36 months
Sustained remission rates/drug-free remission rates	36 months

Countries

Netherlands

Outcome results