An Observational Study to Evaluate RoActemra/Actemra (Tocilizumab) Treatment in a Real-Life Setting

Rheumatoid Arthritis Clinical Trial

Official title:

CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664104
• Other study ID #: ML28336
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: March 2, 2015
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA - Italian Medicines Agency
• Study type: Observational

Clinical Trial Summary

This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of RoActemra/Actemra (tocilizumab) therapy in a routine clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Diagnosis of moderate to severe rheumatoid arthritis

• Patients have started RoActemra/Actemra treatment according to routine clinical practice within 3 months prior to study start

• Patients have been given oral and written information about the study and have signed the informed consent form

Exclusion Criteria:

• Patients who have started RoActemra/Actemra treatment more than 3 months prior to site opening

• Patients who have previously received RoActemra/Actemra in a clinical trial setting or for compassionate use

• Patients 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

• Patients with a history of autoimmune disease or joint inflammatory disease other than rheumatoid arthritis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage/schedule used in routine clinical practice		6 months	No
Secondary	Change in treatment regimen		6 months	No
Secondary	Clinical patient characteristics at the time of treatment initiation		6 months	No
Secondary	Disease activity according to joint count evaluation		6 months	No
Secondary	Correlation of C-reactive protein and treatment response		6 months	No
Secondary	Correlation of body mass index (BMI) with treatment response		6 months	No
Secondary	Safety: incidence of adverse events		6 months	No
Secondary	Correlation of C-reactive protein with disability index/morning stiffness/VAS fatigue		6 months	No
Secondary	Correlation of body mass index with disability disability index/morning stiffness/VAS fatigue		6 months	No