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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01951170




Registration number
NCT01951170
Ethics application status
Date submitted
23/09/2013
Date registered
26/09/2013
Date last updated
21/09/2016

Titles & IDs
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)
Secondary ID [1] 0 0
ML28703
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tocilizumab

Experimental: Tocilizumab - Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.


Treatment: Drugs: Tocilizumab
162 milligrams (mg) tocilizumab was administered subcutaneously once weekly for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Genant-modified Total Sharp Score (mTSS)
Timepoint [1] 0 0
From baseline to Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission
Timepoint [1] 0 0
At Week 24
Secondary outcome [2] 0 0
Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses
Timepoint [2] 0 0
From baseline to Week 24
Secondary outcome [3] 0 0
Percentage of Participants With European League Against Rheumatism (EULAR) Response
Timepoint [3] 0 0
From baseline to Week 24
Secondary outcome [4] 0 0
Change From Baseline in Patient's Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)
Timepoint [4] 0 0
From baseline to Week 24
Secondary outcome [5] 0 0
Change From Baseline in Patient's Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)
Timepoint [5] 0 0
From baseline to Week 24
Secondary outcome [6] 0 0
Change From Baseline in Physician Global Assessment of Disease Activity
Timepoint [6] 0 0
From baseline to Week 24
Secondary outcome [7] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [7] 0 0
From baseline to Week 24
Secondary outcome [8] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Timepoint [8] 0 0
From baseline to Week 24
Secondary outcome [9] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI)
Timepoint [9] 0 0
From baseline to Week 24
Secondary outcome [10] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI)
Timepoint [10] 0 0
From baseline to Week 24
Secondary outcome [11] 0 0
Change From Baseline in Total Tender Joint Count (TJC)
Timepoint [11] 0 0
From baseline to Week 24
Secondary outcome [12] 0 0
Change From Baseline in Swollen Joint Count (SJC)
Timepoint [12] 0 0
From baseline to Week 24
Secondary outcome [13] 0 0
Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions
Timepoint [13] 0 0
From baseline to Week 24
Secondary outcome [14] 0 0
Change From Baseline in RAMRIS Scoring of Cartilage Loss
Timepoint [14] 0 0
From baseline to Week 24
Secondary outcome [15] 0 0
Change From Baseline in RAMRIS Scoring of Synovitis
Timepoint [15] 0 0
From baseline to Week 24
Secondary outcome [16] 0 0
Change From Baseline in RAMRIS Scoring of Osteitis
Timepoint [16] 0 0
From baseline to Week 24
Secondary outcome [17] 0 0
Safety: Percentage of Participants With Adverse Events (AEs)
Timepoint [17] 0 0
Up to Week 32 (end of follow up: 8 weeks after end of treatment)
Secondary outcome [18] 0 0
Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal
Timepoint [18] 0 0
Up to Week 32 (end of follow up: 8 weeks after end of treatment)
Secondary outcome [19] 0 0
Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity
Timepoint [19] 0 0
At baseline, Week 32 (end of follow up: 8 weeks after end of treatment)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Southport
Recruitment hospital [5] 0 0
- Adelaide
Recruitment hospital [6] 0 0
- Hobart
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Ivanhoe
Recruitment hospital [9] 0 0
- Malvern East
Recruitment hospital [10] 0 0
- Morwell
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [9] 0 0
3145 - Malvern East
Recruitment postcode(s) [10] 0 0
3842 - Morwell

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in
patients with active moderate to severe rheumatoid arthritis. Participants will receive a
subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment
is 24 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01951170
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries