Clinical trial NCT02251860: Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharma Europe Ltd.
First posted: 2014-09-29
Enrollment: 1454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. Participants will be followed over an observation period of up to 2 years after the initial injection.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participants who at the time of the study inclusion are participating in a different interventional study on rheumatoid arthritis

Primary outcomes:
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
timeFrame: Up to Week 104
measure: Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants
timeFrame: Up to Week 104
Secondary outcomes:
measure: Change from Baseline in Mean DAS28-ESR Score
timeFrame: Baseline up to Week 104
measure: Percentage of Participants with Continuation of Tocilizumab
timeFrame: Up to Week 104
measure: Mean Retention Time of Tocilizumab
timeFrame: Up to Week 104
measure: Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment
timeFrame: From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)
measure: Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)
timeFrame: Up to Week 104
measure: Percentage of Participants with Low Disease Activity Defined by DAS28-ESR
timeFrame: Up to Week 104
measure: Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)
timeFrame: Up to Week 104
measure: Percentage of Participants with Low Disease Activity Defined by CDAI
timeFrame: Up to Week 104
measure: Change from Baseline in Mean CDAI Score
timeFrame: Baseline up to Week 104
measure: Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response
timeFrame: At Month 3 and Month 6
measure: Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)
timeFrame: Up to Week 104
measure: Mean Dose Used for Concomitant GCs
timeFrame: Up to Week 104
measure: Percentage of Participants with Dose Reduction for Concomitant GCs
timeFrame: Up to Week 104
measure: Treatment Satisfaction Visual Analogue Scale (VAS)
timeFrame: Up to Week 104
measure: Treatment User-Friendliness VAS
timeFrame: Up to Week 104
measure: Percentage of Participants with Treatment Adherence
timeFrame: Up to Week 104
measure: Response to Follow-up Treatment in Case of Switch from Tocilizumab
timeFrame: Up to Week 104
measure: Percentage of Participants with Adverse Events During Follow-up Treatment
timeFrame: Up to Week 104
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Up to Week 104
measure: Hannover Functional Ability Questionnaire (FFbH) Score
timeFrame: Up to Week 104
measure: Percentage of Participants by Type of Physical Exercise
timeFrame: Up to Week 104
measure: Percentage of Participants by Frequency of Physical Exercise
timeFrame: Up to Week 104
measure: Percentage of Participants by Duration of Physical Exercise
timeFrame: Up to Week 104
measure: Fatigue-VAS
timeFrame: Up to Week 104
measure: Sleep Disturbance-VAS
timeFrame: Up to Week 104
measure: State-Trait Anxiety Inventory (STAI) Questionnaire
timeFrame: Up to Week 104
measure: Beck Depression Inventory (BDI) Questionnaire
timeFrame: Up to Week 104
measure: Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)
timeFrame: Up to Week 104
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: