Rheumatoid ArthritisNCT01770834
A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 12 sites in 4 countries.
Trial summary
This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 100 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 18 Apr 2013to 25 Jan 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs
Who may be able to join
- Adult patients, >/= 21 years of age
- Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
- Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
- Initiated on RoActemra/Actemra treatment in accordance with the prescribing information
Who cannot join
- Pregnant or lactating women
- Contra-indication to RoActemra/Actemra treatment according to the local labelling
- Previous treatment with tocilizumab
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Women of childbearing potential not using effective methods of contraception as defined by protocol
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Lebanon8 sites
Study site
Beirut, 11-236
Study site
Beirut, 470 Hazmieh
Study site
Beirut, 961
Study site
Beirut, 99999
Study site
Beirut
Study site
Byblos, 1401
Study site
Saida, 652
Study site
Tripoli, 371 Tripoli
United Arab Emirates2 sites
Study site
Dubai, P.O. Box 31500
Study site
Dubai, P.O. Box 8179
About this study
Official title: A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice
This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.
- 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.
Safety: Incidence of adverse events
Measured: approximately 3 years
Secondary outcomes (3)
Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)
Measured: approximately 3 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
Measured: approximately 3 years
Treatment regimens: Concomitant medications
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study start18 Apr 2013
- Primary completion25 Jan 2017
- Study completion25 Jan 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
- 100 participants (estimated)
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
- NCT01770834
- Sponsor's protocol ID
- ML25533
- Status last verified
- Feb 2018
- First submitted
- 16 Jan 2013
- Last updated
- 2 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice
- ClinicalTrials.gov ID
- NCT01770834
- Acronym / sponsor ID
- ML25533
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2013 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 18 Jan 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 prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs
Key inclusion criteria (4 listed)
- Adult patients, >/= 21 years of age
- Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
- Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
- Initiated on RoActemra/Actemra treatment in accordance with the prescribing information
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Contra-indication to RoActemra/Actemra treatment according to the local labelling
- Previous treatment with tocilizumab
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Women of childbearing potential not using effective methods of contraception as defined by protocol
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
Safety: Incidence of adverse events
Time frame: approximately 3 years
3 secondary outcomes
Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)
Time frame: approximately 3 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
Time frame: approximately 3 years
Treatment regimens: Concomitant medications
Time frame: approximately 3 years
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 2 Mar 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
12 sites in 4 countries: 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 12 sites in 4 countries.
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 4 inclusion and 5 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 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Lebanon, United Arab Emirates, Kuwait, Qatar. 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?
Safety: Incidence of adverse events (time frame: approximately 3 years). 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 2 Mar 2018.