An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951170
• Other study ID #: ML28703
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2013
• Last updated: July 1, 2016
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

This open-label, single-arm study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active moderate to severe rheumatoid arthritis. Patients will receive a subcutaneous dose of RoActemra/Actemra 162 mg once weekly. The anticipated time on study treatment is 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients at least 18 years of age

• Patients with a diagnosis of active moderate to severe rheumatoid arthritis (RA)

• Oral corticosteroids and nonsteroidal anti-inflammatory are permitted if on a stable dose regimen for >/= 4 weeks prior baseline

• Permitted non-biologic DMARDs used alone or in combination are allowed if at a stable dose for at least 4 weeks prior to baseline

• Receiving treatment on an outpatient basis, not including RoActemra/Actemra

• Females of childbearing potential and males with female partners of childbearing potential may participate in this study only if using a reliable means of contraception for at least 5 months following the last dose RoActemra/Actemra

• Previous or current treatment with methotrexate with an inadequate response to methotrexate, intolerance to methotrexate or treatment with methotrexate was considered as inappropriate

• Evidence of i or more erosions in hands or feet assessed by X-ray attribute to RA or MRI of wrist of MCP joints of dominant hand

Exclusion Criteria:

• 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 rheumatoid arthritis

• Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis

• 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 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

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

• Intraarticular (IA) or parenteral corticosteroids within 4 weeks prior to baseline

• Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation

• Treatment with 2 or more anti-TNFs or any other biologic agent at any time prior to screening

• Evidence of serious uncontrolled concomitant disease (e.g., cardiovascular, nervous system, pulmonary)

• History of diverticulitis, diverticulosis requiring antibiotic treatment, or chromic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GU conditions that might predispose to perforation

• Known active current or history of recurrent infections

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)
tocilizumab 162 mg subcutaneously once weekly for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in Genant-modified total Sharp score (mTSS)		From screening to Week 24	No
Secondary	Change in Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) remission (defined as DAS28<2.6)		From baseline to Week 24	No
Secondary	Change in American College of Rheumatology (ACR20/50/70) response		From baseline to Week 24	No
Secondary	Change in European League Against Rheumatism (EULAR) Response		From baseline to Week 24	No
Secondary	Change in Simplified Disease Activity Index (SDAI)		From baseline to Week 24	No
Secondary	Change in Clinical Disease Activity Index (CDAI)		From baseline to Week 24	No
Secondary	Change in total tender joint count (TJC)		From baseline to Week 24	No
Secondary	Change in swollen joint count (SJC)		From baseline to Week 24	No
Secondary	Change in Patient Reported Outcomes		From baseline to Week 24	No
Secondary	Safety: Adverse events		24 weeks	No
Secondary	Safety: Assessment of immunogenicity		32 weeks	No
Secondary	Absolute change from baseline in rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS) scoring of erosions, synovitis, cartilage loss and osteitis.		From baseline to Week 24	No