Rheumatoid ArthritisCOGNOSNCT03291457
A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 22 sites in Belgium.
Trial summary
This prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab and Glucocorticoid Agent
- Type of treatment
- Injection or infusion
- How many people
- 101 participants
- Where
- 22 sitesBelgium
- Study dates
- 30 Mar 2017to 4 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will follow participants with RA who are receiving glucocorticoids prior to start of tocilizumab in daily clinical practice.
Who may be able to join
- Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7
- Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
- Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
- Treated with glucocorticoids for RA when starting tocilizumab treatment
Who cannot join
- Treatment with any investigational agent within 4 weeks or 5 half-lives before tocilizumab
- Continuous or regular treatment with oral corticosteroids for any indication other than RA
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Belgium22 sites
ASZ Aalst
Aalst, 9300
Onze Lieve Vrouwziekenhuis Aalst
Aalst, 9300
Dr. Huppertz - Marx pgmbh
Amel, 4770
Private Practice Els Van Essche
Bonheiden, 2820
AZ Sint Jan
Bruges, 8000
CHU St Pierre (César de Paepe)
Brussels, 1000
Hospital Erasme
Brussels, 1070
Rhumarc sciv sprl
Céroux-Mousty, 1341
UZ Antwerpen
Edegem, 2650
Rhumaconsult sciv sprl; Private Practice
Forchies-la-Marche, 6141
Reumacentrum Genk
Genk, 3600
Reumaclinic
Genk, 3600
AZ Sint Lucas (Sint Lucas)
Ghent, 9000
GHdC Site Saint-Joseph
Gilly (Charleroi), 6000
CHC MontLégia
Liège, 4000
CHU de Liège; Rhumatologie
Liège, 4000
Heilig Hartziekenhuis vzw
Lier, 2500
Private Practice; Reumatologie
Mechelen, 2800
AZ Damiaan
Ostend, 8400
AZ Alma vzw (Sijsele)
Sijsele, 8340
AZ Turnhout Sint Jozef
Turnhout, 2300
AZ Sint Jozef Malle
Westmalle, 2390
About this study
Official title: A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
This prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. All visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab, Glucocorticoid Agent
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra
For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.
Glucocorticoid AgentDrug
Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoids + Tocilizumab | Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab. Receives: Drug: Tocilizumab; Drug: Glucocorticoid Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)
Measured: Week 52
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28
Measured: Week 52
Percentage of Participants by Reason for Glucocorticoid Dose Modification
Measured: Baseline up to Week 52
Secondary outcomes (15)
Glucocorticoid Dose
Measured: Baseline; Weeks 24 and 52
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%
Measured: Weeks 24 and 52
Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%
Measured: Weeks 24 and 52
Time to First Glucocorticoid Dose Reduction
Measured: Baseline up to Week 52
Time to Glucocorticoid Discontinuation
Measured: Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction
Measured: Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
Measured: Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids
Measured: Baseline up to Week 52
Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction
Measured: Baseline up to Week 52
Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
Measured: Baseline up to Week 52
Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids
Measured: Baseline up to Week 52
Glucocorticoid Dose among Participants in Remission According to DAS28
Measured: Baseline up to Week 52
Glucocorticoid Dose among Participants with LDA According to DAS28
Measured: Baseline up to Week 52
Correlation between DAS28 Score and Glucocorticoid Dose
Measured: Baseline up to Week 52
Percentage of Participants with Adverse Events
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start30 Mar 2017
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
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
- 101 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
- NCT03291457
- Sponsor's protocol ID
- ML39114
- Acronym
- COGNOS
- Status last verified
- May 2020
- First submitted
- 20 Sep 2017
- Last updated
- 18 May 2020
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
- ClinicalTrials.gov ID
- NCT03291457
- Acronym / sponsor ID
- COGNOS / ML39114
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 25 Sep 2017 (actual)
- 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, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. All visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoids + Tocilizumab | – | Drug: Tocilizumab, Drug: Glucocorticoid AgentParticipants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will follow participants with RA who are receiving glucocorticoids prior to start of tocilizumab in daily clinical practice.
Key inclusion criteria (4 listed)
- Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7
- Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
- Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
- Treated with glucocorticoids for RA when starting tocilizumab treatment
Key exclusion criteria (2 listed)
- Treatment with any investigational agent within 4 weeks or 5 half-lives before tocilizumab
- Continuous or regular treatment with oral corticosteroids for any indication other than RA
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 |
|---|---|---|
| TocilizumabAlso: RoActemraFor intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling. | Drug | Glucocorticoids + Tocilizumab |
| Glucocorticoid AgentBecause of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling. | Drug | Glucocorticoids + Tocilizumab |
Primary outcome
Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)
Time frame: Week 52
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28
Time frame: Week 52
Percentage of Participants by Reason for Glucocorticoid Dose Modification
Time frame: Baseline up to Week 52
15 secondary outcomes
Glucocorticoid Dose
Time frame: Baseline; Weeks 24 and 52
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%
Time frame: Weeks 24 and 52
Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%
Time frame: Weeks 24 and 52
Time to First Glucocorticoid Dose Reduction
Time frame: Baseline up to Week 52
Time to Glucocorticoid Discontinuation
Time frame: Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction
Time frame: Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
Time frame: Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids
Time frame: Baseline up to Week 52
Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction
Time frame: Baseline up to Week 52
Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
Time frame: Baseline up to Week 52
Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids
Time frame: Baseline up to Week 52
Glucocorticoid Dose among Participants in Remission According to DAS28
Time frame: Baseline up to Week 52
Glucocorticoid Dose among Participants with LDA According to DAS28
Time frame: Baseline up to Week 52
Correlation between DAS28 Score and Glucocorticoid Dose
Time frame: Baseline up to Week 52
Percentage of Participants with Adverse Events
Time frame: Baseline up to Week 52
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 18 May 2020.
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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
22 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 22 sites in Belgium.
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 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Belgium. 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?
Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28) (time frame: Week 52). The study lists 3 primary outcomes in all. 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 18 May 2020.