A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730456
• Other study ID #: ML28133
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2012
• Last updated: November 1, 2016
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Macedonia: Pharmaceutical Bureau, Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Patients 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

• Receiving treatment on an outpatient basis

• Females of childbearing potential must agree to use at least one adequate method of contraception, including a method with a failure rate of <1% per year, during the treatment period

Exclusion Criteria:

• Pregnant or lactating women

• Patients who have prematurely withdrawn from the WA19926 core study for any reason

• Treatment with an investigational agent or cell-depleting therapies since the last administration of study drug in the WA19926 core study

• Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study

• 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

• Inadequate liver, hematologic or renal function

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

• Known active or history of recurrent infections

• Evidence of active malignant disease, malignancies within the previous 10 years (except for basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years

• Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, up to 104 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Macedonia, The Former Yugoslav Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety: Incidence of adverse events		approximately 3 years	No
Secondary	Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)		from baseline to Week 104	No
Secondary	Change in total tender joint count (TJC) / swollen joint count (SJC)		from baseline to Week 104	No
Secondary	Proportion of patients achieving sustained drug-free remission, defined as clinical remission based on DAS28-ESR <2.6 and/or SDAI </=3 for two consecutive visits (every 12 weeks) followed by RoActemra/Actemra discontinuation after the 2nd visit		approximately 3 years	No
Secondary	Time to rheumatoid arthritis flare in patients who have entered drug-free remission		approximately 3 years	No