An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biologic DMARD and/or Anti-TNF Therapy

Rheumatoid Arthritis Clinical Trial

Official title:

A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362062
• Other study ID #: ML22835
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: December 1, 2015
• Start date: October 2010
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra in patients with moderate to severe rheumatoid arthritis who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each patient during RoActemra/Actemra therapy and on follow-up for a total of 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Active rheumatoid arthritis with inadequate response to existing therapies (DMARDs and/or anti-TNFs)

• Considered eligible for RoActemra/Actemra therapy by the treating physician as per routine clinical practice

Exclusion Criteria:

• Pregnant or breastfeeding females

• Immunization with live/attenuated vaccine within 4 weeks prior to baseline

• History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies

• Know active current or history of recurrent infection

• History of or currently active primary or secondary immunodeficiency or known HIV positive status

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• 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

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		12 months	No
Secondary	Rate of patients achieving Disease Activity Score (DAS 28) reduction of at least 1.2 units		12 months	No
Secondary	Rate of patients achieving DAS 28 < 3.2		12 months	No
Secondary	Rate of patients achieving remission (DAS 28 < 2.6)		12 months	No
Secondary	Rate of patients achieving response according to American College of Rheumatology criteria; ACR20/50/70/90		12 months	No
Secondary	Change in biomarkers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR)		12 months	No
Secondary	Quality of life: Visual analogue scale (global assessment disease activity/pain)		12 months	No