A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

NCT ID: NCT01772316

Last Updated: 2016-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-05-31

Brief Summary

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly (for participants entering from WA22762) or every two weeks (for participants entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab Subcutaneous (SC)

Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.

Group Type: EXPERIMENTAL

tocilizumab

Intervention Type: DRUG

162 mg subcutaneously weekly or every two weeks, 96 weeks

Interventions

tocilizumab

162 mg subcutaneously weekly or every two weeks, 96 weeks

Intervention Type: DRUG

Other Intervention Names

Roactemra

Eligibility Criteria

Inclusion Criteria

• Adult participants, >/= 18 years of age
• Participants who have completed the 97-week WA22762 or 96-week NA25220 core study on subcutaneous or intravenous RoActemra/Actemra and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation
• Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the maximum recommended dose are permitted if on a stable dose regimen for >/= 4 weeks prior to baseline
• Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
• Receiving treatment on an outpatient basis
• Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception

Exclusion Criteria

• Participants who have prematurely withdrawn from the WA22762 or NA25220 core studies for any reason
• Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
• History of severe allergic or anaphylactic reactions to human, humanized or mural monoclonal antibodies
• Evidence of serious uncontrolled concomitant disease
• Current liver disease as determined by the principal investigator
• History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations
• Known active current or history of recurrent infections
• Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• Active tuberculosis requiring treatment within the previous 3 years
• Primary or secondary immunodeficiency (history of or currently active)
• Pregnant or breast feeding women
• Body weight > 150 kilogram (kg)
• Inadequate renal, hepatic or hematologic function
• Positive for hepatitis B or hepatitis C

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Mérida, Badajoz, Spain

Santander, Cantabria, Spain

A Coruña, La Coruña, Spain

Santiago de Compostela, La Coruña, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Málaga, Malaga, Spain

Seville, Sevilla, Spain

San Cristóbal de La Laguna, Tenerife, Spain

Valenica, Valencia, Spain

Barakaldo, Vizcaya, Spain

Bilbao, Vizcaya, Spain

Countries

Spain

Other Identifiers

2012-002632-87

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28488

Identifier Type: -

Identifier Source: org_study_id