Rheumatoid ArthritisNCT01918267
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)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 19 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 226 participants
- Where
- 19 sitesNetherlands
- Study dates
- 10 Apr 2012to 10 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who participated in the U Act Early study (ML22497)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Netherlands19 sites
Medisch Centrum Alkmaar
Alkmaar, 1815 JD
Meander Medisch Centrum; Locatie Lichtenberg
Amersfoort, 3818 ES
Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
Apeldoorn, 7334 DZ
Amphia Ziekenhuis
Breda, 4819 EV
Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie
Gorinchem, 4204 AA
Groene Hart Ziekenhuis
Gouda, 2803 HH
Universitair Medisch Centrum Groningen; Department of Rheumatology
Groningen, 9700RB
Kennemer Gasthuis; Inwendige Geneeskunde
Haarlem, 2035RC
Atrium Medisch Centrum; Nephrology
Heerlen, 6419 PC
Tergooiziekenhuizen, loc. Hilversum
Hilversum, 1213 HX
Spaarne Ziekenhuis; Inwendige Geneeskunde
Hoofddorp, 2134 TM
Medisch Centrum Leeuwarden; Reumatology
Leeuwarden, 8934 AD
Academisch Ziekenhuis Leiden; Dept of Rheumatology
Leiden, 2333 ZA
Ijsselmeer Ziekenhuizen; Interne Geneeskunde
Lelystad, 8233 AA
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3430 EM
St. Maartenskliniek
Nijmegen, 6522 JV
Antonius Ziekenhuis Sneek; Department of Rheumatology
Sneek, 8601 ZK
University Medical Centre Utrecht; Reumatologie en Klinische Immunologie
Utrecht, 3584 GA
Maartenskliniek Woerden
Woerden, 3447 GN
About this study
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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score (DAS28)
Measured: from baseline to Month 36
Secondary outcomes (6)
Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)
Measured: from baseline to Month 36
Measure of progressive joint destruction (vdHSS)
Measured: from baseline of U-Act-Early to Month 24 of U-Act-After
Changes in concomitant medication (especially tapering of corticosteroids)
Measured: from baseline to Months 36
Sustained remission rates/drug-free remission rates
Measured: 36 months
Dose modifications/interruptions of RA treatment
Measured: 36 months
Safety: Incidence of adverse events, adverse events of special interest and serious adverse events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start10 Apr 2012
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918267
- Sponsor's protocol ID
- ML28388
- Status last verified
- May 2018
- First submitted
- 6 Aug 2013
- Last updated
- 11 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01918267
- Acronym / sponsor ID
- ML28388
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2012 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in the U Act Early study (ML22497)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Disease Activity Score (DAS28)
Time frame: from baseline to Month 36
6 secondary outcomes
Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)
Time frame: 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
Changes in concomitant medication (especially tapering of corticosteroids)
Time frame: from baseline to Months 36
Sustained remission rates/drug-free remission rates
Time frame: 36 months
Dose modifications/interruptions of RA treatment
Time frame: 36 months
Safety: Incidence of adverse events, adverse events of special interest and serious adverse events
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 19 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Score (DAS28) (time frame: from baseline to Month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018; AzTrials last refreshed its copy on 29 Oct 2026.