A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01235507
First received: October 15, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Drug: methotrexate
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: Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Disease Activity Score (DAS28) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving remission (DAS28 < 2.6) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in C-reactive protein (CRP) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in Quality of Life: Health Assessment Questionnaire (HAQ), Medical Outcomes Study Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score, Pain visual analogue scale [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Incidence of patients with all-cause discontinuation of RoActemra/Actemra [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: tocilizumab [RoActemra/Actemra]
8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions
Drug: methotrexate
stable dose 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
  • Active moderate to severe rheumatoid arthritis (RA)
  • On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
  • Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
  • Body weight </= 150 kg

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
  • Rheumatic autoimmune disease other than RA
  • Functional class IV according to American College of Rheumatology (ACR) classification
  • Prior history of or current inflammatory joint disease other then RA
  • Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
  • Treatment with any biologic drug that is used in the treatment or RA
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Known active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency
  • Positive for HIV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235507

Locations
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78 000
Sarajevo, Bosnia and Herzegovina, 71000
Tuzla, Bosnia and Herzegovina, 75000
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: NCT01235507     History of Changes
Other Study ID Numbers: ML25303
Study First Received: October 15, 2010
Last Updated: March 3, 2014
Health Authority: Bosnia: Agency for Drugs and Medical Devices of Bosnia and Herzegovina

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Methotrexate
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014