Rheumatoid ArthritisARATANCT02251860
Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,454 participants
- Where
- 1 siteGermany
- Study dates
- 20 May 2014to 23 Jul 2020
- 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: Adult participants with active rheumatoid arthritis who are prescribed subcutaneous tocilizumab treatment by their physician prior to and independent of the inclusion of the participant into the study. Participant can be enrolled into the study at maximum 1 month after first tocilizumab administration if baseline and disease characteristics data are available.
Who may be able to join
- Participants who have not yet been treated with tocilizumab
- Participants who have received the first injection with tocilizumab maximum 1 month before inclusion in the study and the necessary baseline data and disease characteristics are present
Who cannot join
- Participants who at the time of the study inclusion are participating in a different interventional study on rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Germany1 site
CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)
Frankfurt, 60528
About this study
Official title: A Prospective, Non-Interventional Study in Germany to Evaluate the Long-Term Effectiveness and Tolerability of Subcutaneously Administered RoActemra® (Tocilizumab; TCZ) in Patients With Rheumatoid Arthritis in Daily Clinical Practice (as Recommended in Label)
ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.
- 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 |
|---|---|---|
| Participants with Rheumatoid Arthritis | Participants with active rheumatoid arthritis who are prescribed tocilizumab treatment according to the marketing authorization by their physician will be followed under routine conditions over an observation period of up to 2 years if baseline and disease characteristics data are available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment
Measured: Up to Week 104
Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants
Measured: Up to Week 104
Secondary outcomes (28)
Change from Baseline in Mean DAS28-ESR Score
Measured: Baseline up to Week 104
Percentage of Participants with Continuation of Tocilizumab
Measured: Up to Week 104
Mean Retention Time of Tocilizumab
Measured: Up to Week 104
Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment
Measured: From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)
Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)
Measured: Up to Week 104
Percentage of Participants with Low Disease Activity Defined by DAS28-ESR
Measured: Up to Week 104
Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)
Measured: Up to Week 104
Percentage of Participants with Low Disease Activity Defined by CDAI
Measured: Up to Week 104
Change from Baseline in Mean CDAI Score
Measured: Baseline up to Week 104
Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response
Measured: At Month 3 and Month 6
Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)
Measured: Up to Week 104
Mean Dose Used for Concomitant GCs
Measured: Up to Week 104
Percentage of Participants with Dose Reduction for Concomitant GCs
Measured: Up to Week 104
Treatment Satisfaction Visual Analogue Scale (VAS)
Measured: Up to Week 104
Treatment User-Friendliness VAS
Measured: Up to Week 104
Percentage of Participants with Treatment Adherence
Measured: Up to Week 104
Response to Follow-up Treatment in Case of Switch from Tocilizumab
Measured: Up to Week 104
Percentage of Participants with Adverse Events During Follow-up Treatment
Measured: Up to Week 104
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Measured: Up to Week 104
Hannover Functional Ability Questionnaire (FFbH) Score
Measured: Up to Week 104
Percentage of Participants by Type of Physical Exercise
Measured: Up to Week 104
Percentage of Participants by Frequency of Physical Exercise
Measured: Up to Week 104
Percentage of Participants by Duration of Physical Exercise
Measured: Up to Week 104
Fatigue-VAS
Measured: Up to Week 104
Sleep Disturbance-VAS
Measured: Up to Week 104
State-Trait Anxiety Inventory (STAI) Questionnaire
Measured: Up to Week 104
Beck Depression Inventory (BDI) Questionnaire
Measured: Up to Week 104
Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)
Measured: Up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start20 May 2014
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
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
- 1,454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharma Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251860
- Sponsor's protocol ID
- ML29087
- Acronym
- ARATA
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2014
- Last updated
- 22 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Interventional Study in Germany to Evaluate the Long-Term Effectiveness and Tolerability of Subcutaneously Administered RoActemra® (Tocilizumab; TCZ) in Patients With Rheumatoid Arthritis in Daily Clinical Practice (as Recommended in Label)
- ClinicalTrials.gov ID
- NCT02251860
- Acronym / sponsor ID
- ARATA / ML29087
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,454 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharma Europe Ltd.
- Study start
- 20 May 2014 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 29 Sep 2014 (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.
ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Rheumatoid Arthritis | – | –Participants with active rheumatoid arthritis who are prescribed tocilizumab treatment according to the marketing authorization by their physician will be followed under routine conditions over an observation period of up to 2 years if baseline and disease characteristics data are available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with active rheumatoid arthritis who are prescribed subcutaneous tocilizumab treatment by their physician prior to and independent of the inclusion of the participant into the study. Participant can be enrolled into the study at maximum 1 month after first tocilizumab administration if baseline and disease characteristics data are available.
Key inclusion criteria (2 listed)
- Participants who have not yet been treated with tocilizumab
- Participants who have received the first injection with tocilizumab maximum 1 month before inclusion in the study and the necessary baseline data and disease characteristics are present
Key exclusion criteria (1 listed)
- Participants who at the time of the study inclusion are participating in a different interventional study on rheumatoid arthritis
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
Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment
Time frame: Up to Week 104
Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants
Time frame: Up to Week 104
28 secondary outcomes
Change from Baseline in Mean DAS28-ESR Score
Time frame: Baseline up to Week 104
Percentage of Participants with Continuation of Tocilizumab
Time frame: Up to Week 104
Mean Retention Time of Tocilizumab
Time frame: Up to Week 104
Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment
Time frame: From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)
Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)
Time frame: Up to Week 104
Percentage of Participants with Low Disease Activity Defined by DAS28-ESR
Time frame: Up to Week 104
Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)
Time frame: Up to Week 104
Percentage of Participants with Low Disease Activity Defined by CDAI
Time frame: Up to Week 104
Change from Baseline in Mean CDAI Score
Time frame: Baseline up to Week 104
Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response
Time frame: At Month 3 and Month 6
Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)
Time frame: Up to Week 104
Mean Dose Used for Concomitant GCs
Time frame: Up to Week 104
Percentage of Participants with Dose Reduction for Concomitant GCs
Time frame: Up to Week 104
Treatment Satisfaction Visual Analogue Scale (VAS)
Time frame: Up to Week 104
Treatment User-Friendliness VAS
Time frame: Up to Week 104
Percentage of Participants with Treatment Adherence
Time frame: Up to Week 104
Response to Follow-up Treatment in Case of Switch from Tocilizumab
Time frame: Up to Week 104
Percentage of Participants with Adverse Events During Follow-up Treatment
Time frame: Up to Week 104
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Time frame: Up to Week 104
Hannover Functional Ability Questionnaire (FFbH) Score
Time frame: Up to Week 104
Percentage of Participants by Type of Physical Exercise
Time frame: Up to Week 104
Percentage of Participants by Frequency of Physical Exercise
Time frame: Up to Week 104
Percentage of Participants by Duration of Physical Exercise
Time frame: Up to Week 104
Fatigue-VAS
Time frame: Up to Week 104
Sleep Disturbance-VAS
Time frame: Up to Week 104
State-Trait Anxiety Inventory (STAI) Questionnaire
Time frame: Up to Week 104
Beck Depression Inventory (BDI) Questionnaire
Time frame: Up to Week 104
Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)
Time frame: Up to Week 104
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 22 Sep 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
1 site 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 1 site in Germany.
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 1 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment (time frame: Up to Week 104). The study lists 2 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 22 Sep 2020.