A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis

Hoffmann-La Roche15 enrolled

Overview

This open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

Tocilizumab 8 mg/kg administered intravenously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult participants, \>/= 18 years of age * Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, according to the Investigator's assessment * No current or recent adverse event or laboratory finding preventing the use of the study drug dose of tocilizumab 8 mg/kg at baseline visit * Women of childbearing potential must agree to use adequate contraception as defined by protocol during and up to 3 months after treatment Exclusion Criteria: * Pregnant females * Participants who have withdrawn prematurely from the WA19926 core study for any reason * Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 * Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926 * Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 * Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis * Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients * Evidence of severe uncontrolled concomitant disease or disorder * Known active or history of recurrent infections * Active tuberculosis requiring treatment in the previous 3 years * History of alcohol, drug or chemical abuse since inclusion in the WA19926 study

Locations (6)

Unnamed facility

Cahors, France

Unnamed facility

Montpellier, France

Unnamed facility

Mulhouse, France

Unnamed facility

Orléans, France

Unnamed facility

Paris, France

Outcomes

Primary Outcomes

Percentage of Participants With Any Adverse Event (AE)

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator's judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant.

Time frame: Up to 160 weeks

Secondary Outcomes

Percentage of Participants With at Least One Clinical Remission Period

Clinical remission: Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) less than (\<)2.6 and/or Simplified Disease Activity Index (SDAI) less than or equal to (≤)3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0-10, with higher scores corresponding to greater disease activity. SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0-86, where lower scores indicate less disease activity.

Time frame: Up to approximately 148 weeks

Percentage of Participants With at Least One Drug-Free Period

Drug-free remission period was defined as clinical remission for at least 2 consecutive assessment visits (every 12 weeks) AND without tocilizumab administration during this clinical remission period.

Data from ClinicalTrials.gov

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Unnamed facility

Toulouse, France

Time frame: Up to approximately 148 weeks

Cumulative Time of Remission Per Participant Over the Extension Study Period

Clinical remission was defined as DAS28-ESR \<2.6 and/or SDAI ≤3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. SDAI scores range from 0 to 86, where lower scores indicate less disease activity.

Time frame: Up to approximately 148 weeks

Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare

An RA flare was defined as an increase in DAS28-ESR from the previous available visits of \>1.2, or \>0.6 if current DAS28-ESR ≥3.2. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.

Time frame: Up to approximately 148 weeks

Time to RA Flare Following Remission or Drug-Free Remission

Time to RA flare was defined as period of clinical remission or drug-free remission followed by flare of DAS28-ESR (increase in DAS28-ESR from the previous available visits of \>1.2, or \>0.6 if current DAS28-ESR ≥3.2). In the case of several remission periods for the same participant, the largest period was used.

Time frame: Up to approximately 148 weeks

Change From Day 1 in DAS28-ESR Scores Over Time

DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.