Clinical trial NCT01772316: A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: A Multicenter, Open-label, Long-term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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* Participants who have prematurely withdrawn from the WA22762 or NA25220 core studies for any reason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

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE)
timeFrame: Baseline up to follow-up (Week 104)
measure: Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response
timeFrame: Baseline up to follow-up (Week 104)
measure: Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in DAS28-ESR at Week 96
timeFrame: Baseline, Week 96
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in SDAI at Week 96
timeFrame: Baseline, Week 96
measure: Change From Baseline in Total Tender Joint Count (TJC) at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Total TJC at Week 96
timeFrame: Baseline, Week 96
measure: Change From Baseline in Swollen Joint Count (SJC) at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in SJC at Week 96
timeFrame: Baseline, Week 96
Secondary outcomes:
measure: Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96
timeFrame: Week 48, Week 96
measure: Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation
timeFrame: Randomization of first participant to clinical cutoff date (19MAY2015) (approximately 29 months)
measure: Patient Global Visual Analog Score (VAS) at Specified Time Points
timeFrame: Baseline, Week 48, Week 96
measure: Patient Pain VAS Score at Specified Time Points
timeFrame: Baseline, Week 48, Week 96
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points
timeFrame: Baseline, Week 48, Week 96
Other outcomes:
Locations:
city: Merida
country: Spain
state: Badajoz
city: Santander
country: Spain
state: Cantabria
city: La Coruna
country: Spain
state: La Coruña
city: Santiago De Compostela
country: Spain
state: La Coruña
city: La Laguna
country: Spain
state: Tenerife
city: Valenica
country: Spain
state: Valencia
city: Barakaldo
country: Spain
state: Vizcaya
city: Bilbao
country: Spain
state: Vizcaya
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: