A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis

NCT ID: NCT00721123

Last Updated: 2013-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2012-05-31

Brief Summary

This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.

Detailed Description

The primary objective of this extension study was to assess the long-term safety of 8 mg/kg tocilizumab with regard to adverse events (AEs) and laboratory result abnormalities.

The secondary objectives were as follows:

• To explore the possibility of reducing concomitant steroid treatment
• To determine the long-term efficacy of 8 mg/kg tocilizumab with regard to reduction in signs and symptoms
• To better understand and predict tocilizumab efficacy, response, safety, and progression of rheumatoid arthritis (RA) and associated diseases with regard to its effect on biomarkers

No viable biomarkers for TCZ treatment effects were identified from the controlled studies. There were, therefore, no biomarkers that warranted further investigation in long-term studies, so no biomarker data are reported.

The extension study WA18695 was an open-label, international multi-center study in patients with moderate to severe active rheumatoid arthritis (RA) who had completed treatment in the 24 weeks placebo-controlled Phase III study WA17822. Patients entering WA17822 had an inadequate response to methotrexate (MTX), and, during WA17822, patients had received treatment with intravenous infusions of tocilizumab 4 mg/kg, 8 mg/kg, or placebo every 4 weeks with background MTX therapy.

All patients who completed the planned course of treatment or escape therapy in the WA17822 study were eligible to enter the WA18695 long-term extension study, where they were assigned to treatment with 8 mg/kg RoActemra/Actemra plus MTX. The dose of RA medications such as MTX and nonsteroidal anti-inflammatory drugs (NSAIDs), but excluding corticosteroids, was to be kept stable for the first 48 weeks of the WA18695 study. During this time dose reductions in these treatments were only allowed as clinically required for safety reasons. After week 48, the administration of disease-modifying antirheumatic drugs (DMARDs) and NSAIDs could be changed, according to the investigator's practice and as tolerated by the patient.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab 8 mg/kg

All participants received tocilizumab 8 mg/kg to a maximum of 800 mg, administered by intravenous (IV) infusion over one hour, every 4 weeks. Concomitant therapies were limited to dosage and administration constraints detailed in the protocol.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Tocilizumab (myeloma receptor antibody \[MRA\]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.

Interventions

Tocilizumab

Tocilizumab (myeloma receptor antibody \[MRA\]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.

Intervention Type: DRUG

Other Intervention Names

RoActemra; Actemra; Tocilizumab (MRA); TCZ

Eligibility Criteria

Inclusion Criteria

• Patients who have completed participation in the Phase III study WA17822 (NCT00106548) in adult rheumatoid arthritis.

Exclusion Criteria

• Treatment with any investigational agent since the last administration of study drug in WA17822.
• Treatment with intravenous (IV) gammaglobulin, plasmapheresis, or Prosorba column since the last administration of study drug in WA17822.
• Treatment with an anti-tumor necrosis factor or anti-interleukin-1 agent, or a T cell costimulation modulator since the last administration of study drug in WA17822.
• Previous treatment with any cell-depleting therapies.
• Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Adelaide, , Australia

Maroochydore, , Australia

Shenton Park, , Australia

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Porto Alegre, , Brazil

São Paulo, , Brazil

Sofia, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Victoria, British Columbia, Canada

Winnipeg, Manitoba, Canada

St. John's, Newfoundland and Labrador, Canada

Burlington, Ontario, Canada

Newmarket, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Sainte-Foy, Quebec, Canada

Besançon, , France

Créteil, , France

Le Mans, , France

Paris, , France

Paris, , France

Paris, , France

Bad Bramstedt, , Germany

Bad Nauheim, , Germany

Baden-Baden, , Germany

Berlin, , Germany

Cologne, , Germany

Erlangen, , Germany

Heidelberg, , Germany

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Tuenmen, , Hong Kong

Budapest, , Hungary

Debrecen, , Hungary

Pécs, , Hungary

Beersheba, , Israel

Haifa, , Israel

Haifa, , Israel

Jerusalem, , Israel

Petah Tikva, , Israel

Tel Aviv, , Israel

Cona (ferrara), , Italy

Gazzi, , Italy

Palermo, , Italy

Siena, , Italy

Udine, , Italy

Chihuahua City, , Mexico

Guadalajara, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

México, , Mexico

San Luis Potosí City, , Mexico

Singapore, , Singapore

Singapore, , Singapore

Piešťany, , Slovakia

Bern, , Switzerland

Lausanne, , Switzerland

Bangkok, , Thailand

Bangkok, , Thailand

Chiang Mai, , Thailand

Countries

China; Argentina; Australia; Austria; Brazil; Bulgaria; Canada; France; Germany; Hong Kong; Hungary; Israel; Italy; Mexico; Singapore; Slovakia; Switzerland; Thailand

Other Identifiers

WA18695

Identifier Type: -

Identifier Source: org_study_id