A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01772316
First received: January 17, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This multicenter, open-label, single arm, long-term extension study will evaluat e the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with mo derate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Patients will receive RoActemra/Actemra 162 mg s ubcutaneously weekly (for patients entering from WA22762) or every two weeks (fo r patients entering from NA25220) for 96 weeks, with telephone call follow-up vi sits at Weeks 100 and 104.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A MULTICENTER, OPEN-LABEL LONG-TERM EXTENSION STUDY OF WA22762 AND NA25220 TO EVALUATE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Long-term safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 96 ] [ Designated as safety issue: No ]
  • Change in total tender joint count (TJC) / swollen joint count (SJC) [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Proportion of patients with remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96 [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients with DMARD/corticosteroid dose reductions and/or discontinuation [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Long-term patient compliance [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: December 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra SC Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly or every two weeks, 96 weeks

  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
  • Patients who have completed the 97-week WA22762 or 96-week NA25220 core study on subcutaneous or intravenous RoActemra/Actemra and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation
  • Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the maximum recommended dose are permitted if on a stable dose regimen for >/= 4 weeks prior to baseline
  • Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
  • Receiving treatment on an outpatient basis
  • Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception

Exclusion Criteria:

  • Patients who have prematurely withdrawn from the WA22762 or NA25220 core studies for any reason
  • Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
  • History of severe allergic or anaphylactic reactions to human, humanized or mural monoclonal antibodies
  • Evidence of serious uncontrolled concomitant disease
  • Current liver disease as determined by the principal investigator
  • History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations
  • Known active current or history of recurrent infections
  • 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
  • Active TB requiring treatment within the previous 3 years
  • Primary or secondary immunodeficiency (history of or currently active)
  • Pregnant or breast feeding women
  • Body weight > 150 kg
  • Inadequate renal, hepatic or hematologic function
  • Positive for hepatitis B or hepatitis C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772316

Locations
Spain
Merida, Badajoz, Spain, 06800
Santander, Cantabria, Spain, 39008
La Coruna, La Coruña, Spain, 15006
Santiago De Compostela, La Coruña, Spain, 15706
La Laguna, Tenerife, Spain, 38320
Valenica, Valencia, Spain, 46009
Barakaldo, Vizcaya, Spain, 48903
Bilbao, Vizcaya, Spain, 48013
Madrid, Spain, 28046
Madrid, Spain, 28007
Malaga, Spain, 29010
Sevilla, Spain, 41009
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: NCT01772316     History of Changes
Other Study ID Numbers: ML28488, 2012-002632-87
Study First Received: January 17, 2013
Last Updated: August 4, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014