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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02046616
• Date of registration: 24/01/2014
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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)
• Scientific title: 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: May 28, 2014
• Target sample size: 133
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02046616
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Denmark, Finland, Norway, Sweden

Contacts

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

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Non-Biologic DMARDs

Drug: Methotrexate

Drug: Tocilizumab

Primary Outcome(s)

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Number of Participants With Neutralizing Anti-Tocilizumab Antibodies [Time Frame: Baseline to FU Week 8 (up to 32 weeks overall)]

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]

Change From Baseline in SJC [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]

Change From Baseline in TJC [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]

Percentage of Participants With American College of Rheumatology (ACR) Response [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24]

Tocilizumab Concentration [Time Frame: Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)]

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]

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]

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]

Change From Baseline in Simplified Disease Activity Index (SDAI) [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]

Compliance With Treatment According to Percentage of Injections Administered [Time Frame: Baseline up to Week 24]

Change From Baseline in HAQ-DI Score [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24]

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]

Percentage of Participants With At Least One Adverse Event Leading to Dosage Modification [Time Frame: Baseline up to Week 24]

Percentage of Participants With European League Against Rheumatism (EULAR) Response [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24]

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)]

Secondary ID(s)

2013-002007-34

ML28691

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02046616