A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic DMARDs - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by (Responsible Party):	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00891020

Purpose

This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. Patients will be randomized to receive tocilizumab either 4mg/kg iv or 8mg/kg iv with concomitant non-biologic DMARDs, or 8mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra] Drug: Nonbiologic DMARDs of investigator's choice	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Atlizumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Serious adverse events [ Time Frame: Throughout study, to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events of special interest [ Time Frame: Throughout study, to week 24 ] [ Designated as safety issue: No ]
ACR20/50/70, DAS28, RAPID, Fatigue VAS [ Time Frame: Throughout study, to week 24 ] [ Designated as safety issue: No ]
Evaluation of risk management guidelines for abnormal lab parameters (neutrophils, platelets, liver enzymes, lipids) [ Time Frame: Throughout study, to week 24 ] [ Designated as safety issue: No ]

Enrollment:	889
Study Start Date:	May 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: tocilizumab [RoActemra/Actemra] 8mg/kg every 4 weeks for 24 weeks
Experimental: 2	Drug: tocilizumab [RoActemra/Actemra] 4mg/kg every 4 weeks for 24 weeks Drug: Nonbiologic DMARDs of investigator's choice As prescribed
Experimental: 3	Drug: tocilizumab [RoActemra/Actemra] 8mg/kg every 4 weeks for 24 weeks Drug: Nonbiologic DMARDs of investigator's choice As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
moderate to severe active rheumatoid arthritis for >6 months;
inadequate clinical response or unable to tolerate current or prior biologic or non-biologic DMARD therapy;
SJC >/=4 and TJC >/=4
body weight </=150kg
current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to baseline;

Exclusion Criteria:

history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
functional class IV as defined by the ACR Classification of Functional Status in rheumatoid arthritis;
treatment with rituximab within 6 months before screening;
intraarticular corticosteroids within 8 weeks or im/iv corticosteroids within 12 weeks prior to screening;
known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891020

Show 228 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00891020 History of Changes
Other Study ID Numbers:	ML22533
Study First Received:	April 29, 2009
Last Updated:	January 11, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases

Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012