An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis
An Observational Study of the Efficacy of RoActemra in Smoking vs Non-smoking Patients With Rheumatoid Arthritis.
1 other identifier
observational
197
2 countries
29
Brief Summary
This observational study will assess the efficacy and safety of RoActemra/Actemra (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from patients treated in routine clinical practice with intravenous RoActemra/Actemra will be collected for 12 months each.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2010
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedNovember 2, 2016
November 1, 2016
3.2 years
April 15, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change in disease activity score (DAS 28)
12 months
Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice
36 months
Secondary Outcomes (5)
Safety: Incidence of adverse events
36 months
Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire
12 months
Rate of patients achieving remission (DAS <2.6)
36 months
Change in blood lipids
12 months
Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate
36 months
Study Arms (1)
Cohort
Eligibility Criteria
Rheumatoid arthritis patients on treatment with RoActemra/Actemra
You may qualify if:
- Adult patients, \> 18 years of age
- Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria
- Treatment with RoActemra/Actemra
You may not qualify if:
- Participation in interventional clinical studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Ålesund, 6017, Norway
Unknown Facility
Bergen, 5053, Norway
Unknown Facility
Drammen, 3004, Norway
Unknown Facility
Gjettum, 1346, Norway
Unknown Facility
Kristiansand, 4604, Norway
Unknown Facility
Levanger, 7600, Norway
Unknown Facility
Lillehammer, 2609, Norway
Unknown Facility
Skien, 3722, Norway
Unknown Facility
Trondheim, 7030, Norway
Unknown Facility
Eskilstuna, 631 88, Sweden
Unknown Facility
Falun, 79182, Sweden
Unknown Facility
Farsta, 541 85, Sweden
Unknown Facility
Gothenburg, 413 45, Sweden
Unknown Facility
Kalmar, 39185, Sweden
Unknown Facility
Karlstad, 65185, Sweden
Unknown Facility
Kristianstad, 29185, Sweden
Unknown Facility
Linköping, 58185, Sweden
Unknown Facility
Luleå, 97180, Sweden
Unknown Facility
Malmo, 205 02, Sweden
Unknown Facility
Oskarström, 31392, Sweden
Unknown Facility
Örebro, 70185, Sweden
Unknown Facility
Östersund, 831 02, Sweden
Unknown Facility
Simrishamn, 272 81, Sweden
Unknown Facility
Skövde, 54185, Sweden
Unknown Facility
Stockholm, 171 76, Sweden
Unknown Facility
Stockholm, 205 02, Sweden
Unknown Facility
Uddevalla, 45180, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Unknown Facility
Västerås, 72189, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2011
First Posted
April 18, 2011
Study Start
August 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11