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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

Macedonia, The Former Yugoslav Republic of

Study Type

Interventional

Intervention

tocilizumab [RoActemra/Actemra]

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Patients who have prematurely withdrawn from the WA19926 core study for any reason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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RoActemra/Actemra

Arm Description

Outcomes

Primary Outcome Measures

Long-term safety: Incidence of adverse events

Secondary Outcome Measures

Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)

Change in total tender joint count (TJC) / swollen joint count (SJC)

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

Time to rheumatoid arthritis flare in patients who have entered drug-free remission

Full Information

NCT ID

NCT01730456

First Posted

November 15, 2012

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01730456

Brief Title

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

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RoActemra/Actemra

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

tocilizumab [RoActemra/Actemra]

Intervention Description

8 mg/kg iv every 4 weeks, up to 104 weeks

Primary Outcome Measure Information:

Title

Long-term safety: Incidence of adverse events

Time Frame

approximately 3 years

Secondary Outcome Measure Information:

Title

Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)

Time Frame

from baseline to Week 104

Title

Change in total tender joint count (TJC) / swollen joint count (SJC)

Time Frame

from baseline to Week 104

Title

Time Frame

approximately 3 years

Title

Time to rheumatoid arthritis flare in patients who have entered drug-free remission

Time Frame

approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Skopje

ZIP/Postal Code

1000

Country

Macedonia, The Former Yugoslav Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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