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

NCT00721123 | Completed Phase 3 Results

• 1 other identifier: WA18695
• Study Type: interventional
• Target: 538
• Locations: 16 countries
• Sites: 66

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Adverse Event (AE) Summary Over Time

  The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.

  through 264 Weeks

• Summary Adverse Event Rates Over Time

  Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied. Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed "unrelated" to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity. Medical confirmation of the AESI "GI perforation" was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs).

  through 264 Weeks

• Overall Death Rate Over Time

  Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure.

  through 264 Weeks

Secondary Outcomes (10)

• Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks

  through 264 Weeks

• Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks

  through 264 Weeks

• Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks

  through 264 Weeks

• Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks

  through 264 Weeks

• Change From Baseline in Scores for Health Assessment Questionnaire - Disability Index Over Time, Through 264 Weeks

  through 264 Weeks

Study Arms (1)

Tocilizumab 8 mg/kg

EXPERIMENTAL

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.

Drug: Tocilizumab

Interventions

Tocilizumab 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.

Also known as: RoActemra, Actemra, Tocilizumab (MRA), TCZ

Tocilizumab 8 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (69)

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Buenos Aires, 1405, Argentina

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Buenos Aires, C1015ABO, Argentina

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Buenos Aires, C1428DQG, Argentina

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Adelaide, 5041, Australia

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Maroochydore, 4558, Australia

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Shenton Park, 6008, Australia

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Vienna, 1090, Austria

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Vienna, 1130, Austria

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Vienna, 1160, Austria

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Porto Alegre, 91350-200, Brazil

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São Paulo, 04027-000, Brazil

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Sofia, 1606, Bulgaria

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Sofia, 1784, Bulgaria

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Varna, 9010, Bulgaria

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Calgary, Alberta, T2N 2T9, Canada

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Victoria, British Columbia, V8V 3P9, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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St. John's, Newfoundland and Labrador, A1A 5E8, Canada

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Burlington, Ontario, L7R 1E2, Canada

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Newmarket, Ontario, L3Y 3R7, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2L 1S6, Canada

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Sainte-Foy, Quebec, G1W 4R4, Canada

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Besançon, 25030, France

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Créteil, 94010, France

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Le Mans, 72000, France

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Paris, 75475, France

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Paris, 75571, France

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Paris, 75679, France

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Bad Bramstedt, 24576, Germany

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Bad Nauheim, 61231, Germany

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Baden-Baden, 76530, Germany

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Berlin, 14059, Germany

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Cologne, 50924, Germany

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Erlangen, 91056, Germany

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Heidelberg, 69120, Germany

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Hong Kong, 852, Hong Kong

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Hong Kong, Hong Kong

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Tuenmen, 852, Hong Kong

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Budapest, 1023, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7632, Hungary

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Beersheba, 84101, Israel

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Haifa, 31048, Israel

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Haifa, 31096, Israel

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Jerusalem, 91120, Israel

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Petah Tikva, 49100, Israel

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Tel Aviv, 64239, Israel

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Cona (ferrara), 44124, Italy

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Gazzi, 98125, Italy

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Palermo, 90127, Italy

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Siena, 53100, Italy

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Udine, 33100, Italy

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Chihuahua City, 31000, Mexico

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Guadalajara, 44690, Mexico

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Mexico City, 07760, Mexico

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Mexico City, 14080, Mexico

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México, 44620, Mexico

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San Luis Potosí City, 78240, Mexico

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Singapore, 119074, Singapore

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Singapore, 258499, Singapore

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Piešťany, 921 01, Slovakia

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Bern, 3010, Switzerland

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Lausanne, 1011, Switzerland

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 23, 2008
• Study Start: August 1, 2005
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 28, 2013
• Results First Posted: October 21, 2013

Record last verified: 2013-11

Locations

AR (3); SG (2); AU (3); IL (6); TH (3); FR (6); SL (1); BR (2); BU (3); HU (3); CA (11); ME (6); CH (2); DE (7); HK (3); IT (5)