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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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: tocilizumab [RoActemra/Actemra] (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Long-term safety: Incidence of adverse events

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Skopje 1000, Macedonia, The Former Yugoslav Republic of
Additional Information

Starting date: October 2012
Last updated: August 17, 2015

Page last updated: August 23, 2015

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