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

NCT01655381 | Completed Phase 3 Results

• 2 other identifiers: ML281742011-005516-29
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 160 weeks

Secondary Outcomes (16)

• Percentage of Participants With at Least One Clinical Remission Period

  Up to approximately 148 weeks

• Percentage of Participants With at Least One Drug-Free Period

  Up to approximately 148 weeks

• Cumulative Time of Remission Per Participant Over the Extension Study Period

  Up to approximately 148 weeks

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

  Up to approximately 148 weeks

• Time to RA Flare Following Remission or Drug-Free Remission

  Up to approximately 148 weeks

Study Arms (1)

Tocilizumab

EXPERIMENTAL

Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Tocilizumab 8 mg/kg administered intravenously.

Also known as: RoActemra®, Actemra®

Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Cahors, 46005, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Mulhouse, 68070, France

Location

Unknown Facility

Orléans, 45032, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Locations

FR (6)