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)

May 10, 2018 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar
      • Amersfoort, Netherlands, 3818 ES
        • Meander Medisch Centrum; Locatie Lichtenberg
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • Gorinchem, Netherlands, 4204 AA
        • Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie
      • Gouda, Netherlands, 2803 HH
        • Groene Hart Ziekenhuis
      • Groningen, Netherlands, 9700RB
        • Universitair Medisch Centrum Groningen; Department of Rheumatology
      • Haarlem, Netherlands, 2035RC
        • Kennemer Gasthuis; Inwendige Geneeskunde
      • Heerlen, Netherlands, 6419 PC
        • Atrium Medisch Centrum; Nephrology
      • Hilversum, Netherlands, 1213 HX
        • Tergooiziekenhuizen, loc. Hilversum
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis; Inwendige Geneeskunde
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden; Reumatology
      • Leiden, Netherlands, 2333 ZA
        • Academisch Ziekenhuis Leiden; Dept of Rheumatology
      • Lelystad, Netherlands, 8233 AA
        • Ijsselmeer Ziekenhuizen; Interne Geneeskunde
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis Nieuwegein
      • Nijmegen, Netherlands, 6522 JV
        • St. Maartenskliniek
      • Sneek, Netherlands, 8601 ZK
        • Antonius Ziekenhuis Sneek; Department of Rheumatology
      • Utrecht, Netherlands, 3584 GA
        • University Medical Centre Utrecht; Reumatologie en Klinische Immunologie
      • Woerden, Netherlands, 3447 GN
        • Maartenskliniek Woerden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who participated in the U Act Early study (ML22497)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Disease Activity Score (DAS28)
Time Frame: from baseline to Month 36
from baseline to Month 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)
Time Frame: from baseline to Month 36
from baseline to Month 36
Measure of progressive joint destruction (vdHSS)
Time Frame: from baseline of U-Act-Early to Month 24 of U-Act-After
from baseline of U-Act-Early to Month 24 of U-Act-After
Changes in concomitant medication (especially tapering of corticosteroids)
Time Frame: from baseline to Months 36
from baseline to Months 36
Sustained remission rates/drug-free remission rates
Time Frame: 36 months
36 months
Dose modifications/interruptions of RA treatment
Time Frame: 36 months
36 months
Safety: Incidence of adverse events, adverse events of special interest and serious adverse events
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML28388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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