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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Tocilizumab (RoActemra/Actemra) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Reference Study ID Number: ML28703 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

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.

Clinical Details

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)

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

Primary outcome: Absolute change in Genant-modified total Sharp score (mTSS)

Secondary outcome:

Change in Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) remission (defined as DAS28<2.6)

Change in American College of Rheumatology (ACR20/50/70) response

Change in European League Against Rheumatism (EULAR) Response

Change in Simplified Disease Activity Index (SDAI)

Change in Clinical Disease Activity Index (CDAI)

Change in total tender joint count (TJC)

Change in swollen joint count (SJC)

Change in Patient Reported Outcomes

Safety: Adverse events

Safety: Assessment of immunogenicity

Absolute change from baseline in rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS) scoring of erosions, synovitis, cartilage loss and osteitis.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Reference Study ID Number: ML28703 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Camperdown, New South Wales 2050, Australia; Completed

Coffs Harbour, New South Wales 2450, Australia; Active, not recruiting

Kogarah, New South Wales 2217, Australia; Completed

Southport, Queensland 4215, Australia; Completed

Adelaide, South Australia 5000, Australia; Completed

Hobart, Tasmania 7000, Australia; Completed

Geelong, Victoria 3220, Australia; Active, not recruiting

Ivanhoe, Victoria 3079, Australia; Completed

Malvern East, Victoria 3145, Australia; Recruiting

Morwell, Victoria 3842, Australia; Completed

Additional Information

Starting date: November 2013
Last updated: August 17, 2015

Page last updated: August 23, 2015

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