Rheumatoid ArthritisNCT01613378
A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With Tocilizumab (RoActemra/Actemra)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 32 sites in Canada.
Trial summary
This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 200 participants
- Where
- 32 sitesCanada
- Study dates
- Feb 2012to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
Who may be able to join
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria
- Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
- Informed consent to data being subject to computerized data processing
- Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage
Who cannot join
- Received tocilizumab prior to enrolment visit
- Previously received tocilizumab in a clinical trial or for compassionate use
- Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
- Participation in another clinical trial or industry sponsored observational study
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Canada32 sites
Study site
Brampton, Ontario, L6T 3J1
Study site
Burlington, Ontario, L7L 0B7
Study site
Edmonton, Alberta, T5M 0H4
Study site
Hamilton, Ontario, L8N 2B6
Study site
Kelowna, British Columbia, V1Y 3G8
Study site
Laval, Quebec, H7G 2E6
Study site
Lunenburg, Nova Scotia, B0J 2C0
Study site
Markham, Ontario, L6B 1A1
Study site
Mississauga, Ontario, L5M 2V8
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H2L 1S6
Study site
Montreal, Quebec, H2L 4M1
Study site
Montreal, Quebec, H3T 1Y6
Study site
Nanaimo, British Columbia, V9R 3G9
Study site
Newmarket, Ontario, L3Y 3R7
Study site
Penticton, British Columbia, V2A 3G8
Study site
Pointe-Claire, Quebec, H9R 3J1
Study site
Québec, Quebec, G1V 3M7
Study site
Rimouski, Quebec, G5L 8W1
Study site
Saint-Eustache, Quebec, J7P 4J2
Study site
Saskatoon, Saskatchewan, S7K 0H6
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
St. Catharines, Ontario, L2N 7E4
Study site
St. John's, Newfoundland and Labrador, A1A 5E8
Study site
St. John's, Newfoundland and Labrador, A1C 5B8
Study site
Sydney, Nova Scotia, B1S 3N1
Study site
Toronto, Ontario, M4S 2B8
Study site
Toronto, Ontario, M5G 1X5
Study site
Trois-Rivières, Quebec, G8Z 1Y2
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Victoria, British Columbia, V8P 5P6
Study site
Windsor, Ontario, N8X 5A6
About this study
Official title: A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab
This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- No intervention
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention administered in this study
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis Cohort | The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
Measured: At 6 months
Secondary outcomes (12)
Change From Baseline in Tender Joint Count (TJC)
Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.
Measured: From baseline to Month 12
Change From Baseline in Swollen Joint Count (SJC)
Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.
Measured: From baseline to Month 12
Change From Baseline in Disease Activity Score 28 (DAS28)
The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity.
Measured: From baseline to Month 12
Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness.
Measured: From baseline to Month 12
Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.
Measured: From baseline to Month 12
Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)
With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.
Measured: From baseline to Month 12
Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain.
Measured: From baseline to Month 12
Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)
With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue.
Measured: From baseline to Month 12
Change From Baseline in C-Reactive Protein (CRP)
The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.
Measured: From baseline to Month 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement.
Measured: From baseline to Month 12
Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months
The extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data.
Measured: At 12 months
Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months
The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded "YES" to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 200 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
- NCT01613378
- Sponsor's protocol ID
- ML28121
- Status last verified
- Aug 2016
- First submitted
- 5 Jun 2012
- Last updated
- 4 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results From an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec;5(2):551-565. doi: 10.1007/s40744-018-0130-6. Epub 2018 Oct 28.
PubMed 30370468
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab
- ClinicalTrials.gov ID
- NCT01613378
- Acronym / sponsor ID
- ML28121
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 4 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Cohort | – | Other: No interventionThe cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.
Key inclusion criteria (5 listed)
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria
- Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
- Informed consent to data being subject to computerized data processing
- Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage
Key exclusion criteria (5 listed)
- Received tocilizumab prior to enrolment visit
- Previously received tocilizumab in a clinical trial or for compassionate use
- Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
- Participation in another clinical trial or industry sponsored observational study
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention administered in this study | Other | Rheumatoid Arthritis Cohort |
Primary outcome
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
Time frame: At 6 months
12 secondary outcomes
Change From Baseline in Tender Joint Count (TJC)
Time frame: From baseline to Month 12
Change From Baseline in Swollen Joint Count (SJC)
Time frame: From baseline to Month 12
Change From Baseline in Disease Activity Score 28 (DAS28)
Time frame: From baseline to Month 12
Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)
Time frame: From baseline to Month 12
Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)
Time frame: From baseline to Month 12
Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)
Time frame: From baseline to Month 12
Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)
Time frame: From baseline to Month 12
Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)
Time frame: From baseline to Month 12
Change From Baseline in C-Reactive Protein (CRP)
Time frame: From baseline to Month 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: From baseline to Month 12
Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months
Time frame: At 12 months
Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months
Time frame: At 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30370468Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results From an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec;5(2):551-565. doi: 10.1007/s40744-018-0130-6. Epub 2018 Oct 28.
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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
32 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 32 sites in Canada.
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 5 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613378, which also lists 1 linked publication.
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 4 Oct 2016.