A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis

NCT01649804 | Completed Phase 3 Results

• 2 other identifiers: ML281462011-006125-14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)

  An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.

  End of Study (Week 104 or early withdrawal)

Secondary Outcomes (8)

• Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)

  Screening and End of Study (Week 104 or early withdrawal)

• Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)

  Screening and End of Study (Week 104 or early withdrawal)

• Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)

  Week 12 and Week 104

• Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)

  Week 12 and Week 104

• Time to Rheumatoid Arthritis (RA) Flare

  End of Study (Week 104 or early withdrawal)

Study Arms (1)

RoActemra/Actemra single arm

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg intravenously every 4 weeks for 104 weeks

RoActemra/Actemra single arm

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 who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
• No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
• Receiving treatment on an outpatient basis

You may not qualify if:

• Females who are pregnant
• Participants who have prematurely withdrawn from the core study WA19926 for any reason
• Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
• Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
• Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
• Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
• Abnormal laboratory values

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Budapest, 1027, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Eger, 3300, Hungary

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 23, 2012
• First Posted: July 25, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 4, 2016
• Results First Posted: September 22, 2016

Record last verified: 2016-09

Locations

HU (3)