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

NCT01664598 | Completed Phase 3 Results

• 1 other identifier: ML28124
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

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

  An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE. 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. AESIs included serious infections (including opportunistic infections) and abnormal liver function tests.

  Up to 112 weeks

• Percentage of Adverse Events (AEs) Leading to Dose Modification and AEs Leading to Study Withdrawal

  An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE.

  Up to 112 weeks

• Percentage of Adverse Events With Severity as Mild, Moderate, and Severe

  Up to 112 weeks

Secondary Outcomes (9)

• Percent Change From Baseline in the Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Over Time

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104

• Percent Change From Baseline in the Simplified Disease Activity Index (SDAI) Over Time

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104

• Change From Baseline in Tender Joint Count 66 (TJC 66) Over Time

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104

• Change From Baseline in Swollen Joint Count 66 (SJC 66) Over Time

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104

• Percentage of Participants With Treatment-Free Remission According to DAS28-ESR/SDAI Remission Criteria

  Up to 104 weeks

Study Arms (1)

Tocilizumab

EXPERIMENTAL

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

8 mg/kg administered intravenously (IV) every 4 weeks for 104 weeks

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 according to the Investigator's assessment
• No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
• Women of childbearing potential must agree to use adequate contraception as defined by protocol during the treatment period

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 (12)

Unknown Facility

Moscow, 105203, Russia

Location

Unknown Facility

Moscow, 115522, Russia

Location

Unknown Facility

Moscow, 115682, Russia

Location

Unknown Facility

Moscow, 119049, Russia

Location

Unknown Facility

Moscow, 129327, Russia

Location

Unknown Facility

Ryazan, 390011, Russia

Location

Unknown Facility

Saint Petersburg, 195067, Russia

Location

Unknown Facility

Saratov, 410002, Russia

Location

Unknown Facility

Tula, 300053, Russia

Location

Unknown Facility

Voronezh, 394066, Russia

Location

Unknown Facility

Yaroslavl, 150030, Russia

Location

Unknown Facility

Yekaterinburg, 620102, Russia

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 10, 2012
• First Posted: August 14, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-03

Locations

RU (12)