Skip to main content
OpenTrials
Completed

NCT Number: NCT01918267

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Centrum Alkmaar, Alkmaar, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Disease Activity Score (DAS28)

    Time frame: from baseline to Month 36

Secondary outcomes

  1. Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)

    Time frame: from baseline to Month 36

  2. Measure of progressive joint destruction (vdHSS)

    Time frame: from baseline of U-Act-Early to Month 24 of U-Act-After

  3. Changes in concomitant medication (especially tapering of corticosteroids)

    Time frame: from baseline to Months 36

  4. Sustained remission rates/drug-free remission rates

    Time frame: 36 months

  5. Dose modifications/interruptions of RA treatment

    Time frame: 36 months

  6. Safety: Incidence of adverse events, adverse events of special interest and serious adverse events

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 7, 2013
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.