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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01951170
• Date of registration: 23/09/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
• Scientific 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)
• Date of first enrolment: November 2013
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01951170
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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 disease-modifying anti-rheumatic drugs (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 tocilizumab

- 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 tocilizumab

- 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 one or more erosions in hands or feet assessed by X-ray attributable to RA
or magnetic resonance imaging (MRI) of wrist of metacarpophalangeal (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 American College of Rheumatology (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 tocilizumab 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 intravenous (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-tumor necrosis factor (TNF) agents 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 gastrointestinal (GI) disease such as Crohn's disease, ulcerative
colitis, or other symptomatic lower genitourinary (GU) conditions that might
predispose to perforation

- Known active current or history of recurrent infections



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

Change From Baseline in Genant-modified Total Sharp Score (mTSS) [Time Frame: From baseline to Week 24]

Secondary Outcome(s)

Change From Baseline in RAMRIS Scoring of Synovitis [Time Frame: From baseline to Week 24]

Percentage of Participants With European League Against Rheumatism (EULAR) Response [Time Frame: From baseline to Week 24]

Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity [Time Frame: At baseline, Week 32 (end of follow up: 8 weeks after end of treatment)]

Change From Baseline in Clinical Disease Activity Index (CDAI) [Time Frame: From baseline to Week 24]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [Time Frame: From baseline to Week 24]

Change From Baseline in Patient's Global Assessment of Disease Activity Visual Analog Scale (PGA VAS) [Time Frame: From baseline to Week 24]

Change From Baseline in RAMRIS Scoring of Cartilage Loss [Time Frame: From baseline to Week 24]

Change From Baseline in RAMRIS Scoring of Osteitis [Time Frame: From baseline to Week 24]

Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses [Time Frame: From baseline to Week 24]

Change From Baseline in Patient's Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS) [Time Frame: From baseline to Week 24]

Change From Baseline in Total Tender Joint Count (TJC) [Time Frame: From baseline to Week 24]

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Time Frame: From baseline to Week 24]

Change From Baseline in Physician Global Assessment of Disease Activity [Time Frame: From baseline to Week 24]

Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions [Time Frame: From baseline to Week 24]

Safety: Percentage of Participants With Adverse Events (AEs) [Time Frame: Up to Week 32 (end of follow up: 8 weeks after end of treatment)]

Change From Baseline in Swollen Joint Count (SJC) [Time Frame: From baseline to Week 24]

Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal [Time Frame: Up to Week 32 (end of follow up: 8 weeks after end of treatment)]

Change From Baseline in Simplified Disease Activity Index (SDAI) [Time Frame: From baseline to Week 24]

Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission [Time Frame: At Week 24]

Secondary ID(s)

ML28703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/09/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01951170