Clinical trial NCT01664598: An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid Arthritis
Official title: A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, 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: 2012-08-14
Enrollment: 49
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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* Participants who have withdrawn prematurely from the WA19926 core study for any reason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
* History of alcohol, drug or chemical abuse since inclusion in the WA19926 study

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)
timeFrame: Up to 112 weeks
measure: Percentage of Adverse Events (AEs) Leading to Dose Modification and AEs Leading to Study Withdrawal
timeFrame: Up to 112 weeks
measure: Percentage of Adverse Events With Severity as Mild, Moderate, and Severe
timeFrame: Up to 112 weeks
Secondary outcomes:
measure: Percent Change From Baseline in the Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Over Time
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
measure: Percent Change From Baseline in the Simplified Disease Activity Index (SDAI) Over Time
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
measure: Change From Baseline in Tender Joint Count 66 (TJC 66) Over Time
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
measure: Change From Baseline in Swollen Joint Count 66 (SJC 66) Over Time
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
measure: Percentage of Participants With Treatment-Free Remission According to DAS28-ESR/SDAI Remission Criteria
timeFrame: Up to 104 weeks
measure: Time to Rheumatoid Arthritis Recurrence in Participants Who Achieved Treatment-Free Remission
timeFrame: Up to 104 weeks
measure: Percent Change in Participant's General Assessment of Disease Activity (Severity of Disease) VAS Over Time
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
measure: Percent Change in Participant's Assessment of Pain (VAS) Over Time
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
measure: Change From Baseline in Health Assessment Questionnaire (HAQ-DI) Score Over Time
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Tula
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: