A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

Rheumatoid Arthritis Clinical Trial

Official title:

Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326962
• Other study ID #: ML22726
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2011
• Last updated: October 1, 2015
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Active moderate to severe rheumatoid arthritis of >/= 6 months duration

• >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment

• Inadequate clinical response to non-biologic DMARD or anti-TNF therapy

• Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug

Exclusion Criteria:

• Pregnant or lactating women

• Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment

• Rheumatic autoimmune disease other than RA

• Functional class IV (ACR classification)

• Prior history of or current joint disease other than RA

• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

• Previous treatment with RoActemra/Actemra

• Known active current or history of recurrent infection

• History of or currently active primary or secondary immunodeficiency

• Active tuberculosis requiring treatment within the previous 3 years

• Positive for HIV

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
8 mg/kg (max. 800 mg) iv every 4 weeks, 6 infusions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity score (DAS28)		from baseline to week 24	No
Primary	Proportion of patients achieving remission (DAS28 <2.6)		24 weeks	No
Primary	Time to remission (DAS28 <2.6)		24 weeks	No
Secondary	Safety: Incidence of adverse events		24 weeks	No
Secondary	Response according to American College of Rheumatology (ACR) criteria		24 weeks	No