A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)

NCT01668966 | Completed Phase 3 Results

• 1 other identifier: ML28080
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

Brief Summary

This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator.

  Baseline up to approximately 104 weeks

• Percentage of Participants With TEAEs of Special Interest

  An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories.

  Baseline up to approximately 104 weeks

• Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation

  An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started.

  Baseline up to approximately 104 weeks

Secondary Outcomes (10)

• Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)

• CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)

• CFB in Swollen Joint Count (SJC) at Specified Time Points

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)

• CFB in Tender Joint Count (TJC) at Specified Time Points

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)

• Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued

  Baseline up to approximately 104 weeks

Study Arms (1)

Tocilizumab

EXPERIMENTAL

Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.

Also known as: RoActemra, Actemra

Tocilizumab

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
• No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
• Women of childbearing potential must agree to use highly reliable contraception during the treatment period

You may not qualify if:

• Pregnant or breastfeeding females
• Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
• Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
• 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 (NCT01649804)
• Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
• Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
• Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
• 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 infections or history of recurrent infections
• Active tuberculosis requiring treatment in the previous 3 years

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

CIP - Centro Internacional de Pesquisa

Goiânia, Goiás, 74110-120, Brazil

Location

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Centro de Estudos em Terapias Inovadoras - CETI

Curtiba, Paraná, 80030-110, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

São Paulo, São Paulo, 04026-000, Brazil

Location

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, 04266-010, Brazil

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: August 16, 2012
• First Posted: August 20, 2012
• Study Start: December 9, 2013
• Primary Completion: May 11, 2016
• Study Completion: May 11, 2016
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2019-02

Locations

BR (6)