Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02046616 |
Date of registration:
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24/01/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
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Scientific title:
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Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound. |
Date of first enrolment:
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May 28, 2014 |
Target sample size:
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133 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02046616 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Finland
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Norway
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Sweden
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Contacts
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Name:
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Clinical Trials |
Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
- Moderate to severe RA with a DAS28-ESR score >3.2 points
- Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or
where MTX or other non-biologic DMARDs are inappropriate
- Oral corticosteroids (less than or equal to [ equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable
dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline
- Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to
baseline
- Receiving treatment on an outpatient basis, not including tocilizumab
- Agreement to use reliable means of contraception as defined by protocol, among females
of childbearing potential and males with female partners of childbearing potential
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 RA
- 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 or current inflammatory joint disease other than RA
- Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the
investigational drug, whichever is longer) of screening
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- History of severe allergic or anaphylactic reactions to human, humanized, or murine
monoclonal antibodies
- Evidence of serious concomitant disease or disorder
- Known active current or history of recurrent infection
- Any major episode of infection requiring hospitalization or treatment with intravenous
(IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of
screening
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for hepatitis B or hepatitis C
- History of or current active primary or secondary immunodeficiency
- Pregnant or lactating women
- Neuropathies or other conditions that might interfere with pain evaluation
- Inadequate hematologic, renal, or liver function
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Non-Biologic DMARDs
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Drug: Tocilizumab
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Drug: Methotrexate
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Primary Outcome(s)
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
[Time Frame: Baseline, Week 12]
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Secondary Outcome(s)
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Change From Baseline in Disease Activity Score 28 (DAS28)-Erythrocyte Sedimentation Rate (ESR) Score
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Change From Baseline in HAQ-DI Score
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Compliance With Treatment According to Percentage of Injections Administered
[Time Frame: Baseline up to Week 24]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Percentage of Participants With At Least One Adverse Event Leading to Dosage Modification
[Time Frame: Baseline up to Week 24]
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Percentage of Participants With European League Against Rheumatism (EULAR) Response
[Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24]
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Soluble Interleukin-6 Receptor (sIL-6R) Concentration
[Time Frame: Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)]
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Change From Baseline in Patient Global Assessment of Disease Activity According to VAS
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Change From Baseline in SJC
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Change From Baseline in TJC
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Percentage of Participants With American College of Rheumatology (ACR) Response
[Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24]
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Tocilizumab Concentration
[Time Frame: Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)]
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Number of Participants With Neutralizing Anti-Tocilizumab Antibodies
[Time Frame: Baseline to FU Week 8 (up to 32 weeks overall)]
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Change From Baseline in CDAI at Weeks 2, 4, 8, 16, 20, and 24
[Time Frame: Baseline and Weeks 2, 4, 8, 16, 20, 24]
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Change From Baseline in Patient Global Assessment of RA-Related Pain According to VAS
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Change From Baseline in Simplified Disease Activity Index (SDAI)
[Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]
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Secondary ID(s)
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2013-002007-34
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ML28691
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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