A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting
CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab
1 other identifier
observational
151
1 country
24
Brief Summary
This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.
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 Jun 2012
24 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
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
July 13, 2017
CompletedJuly 13, 2017
April 1, 2017
1.5 years
August 7, 2012
January 26, 2017
April 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants on TCZ Treatment at Month 6
Percentage of participants on TCZ treatment at Month 6 was calculated as: \[(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.
Month 6
Secondary Outcomes (63)
Percentage of Participants by TCZ Dose at Month 6
Month 6
Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Baseline
Time Elapsed From Diagnosis of RA
Baseline (assessed retrospectively)
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
Baseline
Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline
Baseline
- +58 more secondary outcomes
Study Arms (1)
RA Participants
Participants with moderate or severe RA who are under tocilizumab treatment in routine clinical practice (in accordance with the local label) will be observed for 6 months from the start of treatment.
Interventions
Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.
Eligibility Criteria
Participants with moderate to severe RA who are being treated or begin treatment with tocilizumab according to routine clinical practice.
You may qualify if:
- Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria
- Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment
You may not qualify if:
- Participants who have started tocilizumab treatment more than 3 months prior to site opening
- Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use
- Participants who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
- Participants with a history of autoimmune disease or joint inflammatory disease other than RA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Coppito, Abruzzo, 67100, Italy
Unknown Facility
Barletta, Apulia, 76121, Italy
Unknown Facility
Casarano (LE), Apulia, 73042, Italy
Unknown Facility
Foggia, Apulia, 71100, Italy
Unknown Facility
Reggio Calabria, Calabria, 89133, Italy
Unknown Facility
Benevento, Campania, 82100, Italy
Unknown Facility
Telese Terme, Campania, 82037, Italy
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Rome, Lazio, 00128, Italy
Unknown Facility
Bergamo, Lombardy, 24127, Italy
Unknown Facility
Castel Goffredo, Lombardy, 46042, Italy
Unknown Facility
Gavardo, Lombardy, 25085, Italy
Unknown Facility
Milan, Lombardy, 20122, Italy
Unknown Facility
Monza, Lombardy, 20052, Italy
Unknown Facility
Pavia, Lombardy, 27100, Italy
Unknown Facility
Novara, Piedmont, 28100, Italy
Unknown Facility
Catania, Sicily, 95124, Italy
Unknown Facility
Catania, Sicily, 95126, Italy
Unknown Facility
Palermo, Sicily, 90146, Italy
Unknown Facility
Florence, Tuscany, 50139, Italy
Unknown Facility
Pisa, Tuscany, 56100, Italy
Unknown Facility
Cona (Ferrara), Veneto, 44124, Italy
Unknown Facility
Verona, Veneto, 37126, Italy
Unknown Facility
Verona, Veneto, 37134, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 14, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 13, 2017
Results First Posted
July 13, 2017
Record last verified: 2017-04