A Study of the Efficacy and Safety of RoActemra/Actemra in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-label, Multicenter Study to Evaluate Disease Activity and Safety of Treatment With Actemra (Tocilizumab) Administered as Subcutaneous Injection in Adult RA Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988012
• Other study ID #: ML28698
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2013
• Last updated: August 1, 2016
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This open-label, single-arm study will evaluate the safety and efficacy of RoActemra/Actemra alone or concomitant with other antirheumatic drugs when administered as a single, weekly injection in patients with rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients >/= 18 years of age

• Patients with a diagnosis of active RA according to the revised (1987) ACR criteria on EULAR/ACR (2010) criteria

• Patients who were previously treated with:

• Three non-biologic DMARDs, and were not treated with any biologic agent; OR

• One biologic agent (alone or in combination with non-biologic DMARDs), and discontinued that agent for a reason

• Oral corticosteroids (</= 10 mg/day prednisone or equivalent), NSAIDs and non-biologic DMARDs are permitted if on a stable dose regimen for >/= 4 weeks prior to Baseline

• Use of effective contraception throughout the study as defined by protocol; female patients of childbearing potential must not be pregnant

Exclusion Criteria:

• Presence of serious, uncontrolled, clinically significant medical conditions

• History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease that might predispose to perforation

• Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections

• Any infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening

• Clinically significant findings on lab tests and/or hepatitis B or C, or HIV screenings

• Active TB requiring treatments within the previous 3 years

• Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years

• History of alcohol, drug, or chemical abuse within 1 year prior to Screening

• Neuropathies or other conditions that might interfere with pain evaluation

• Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline

• Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted

• Functional Class IV as defined by the ACR Classification of Functional Status in-Rheumatoid Arthritis (Appendix 2)

• Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16

• Prior history of current inflammatory joint disease other than RA

• Exposure to RoActemra/Actemra (either IV or SC) at any time prior to Baseline

• Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening

• Previous treatment with any cell-depleting therapies, including investigational agents approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation

• Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline

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

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]
162 mg administered subcutaneously once a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Patient-reported outcome of disease activity		24 weeks	No
Primary	Efficacy: Change in disease activity, scored on CDAI/SDAI		From baseline to Week 24	No
Primary	Efficacy: Proportion of patients in remission/with lowered disease score		24 weeks	No
Primary	Efficacy: Reduction/discontinuation of parallel therapies.		24 weeks	No
Secondary	Patient-reported quality of life assessment		24 weeks	No
Secondary	Safety: Incidence of adverse events		32 weeks	No
Secondary	Safety: Assessment of immunogenicity		32 weeks	No