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)

NCT01235507 | Completed Phase 3 Results

• 1 other identifier: ML25303
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)

  AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24.

  Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24

Secondary Outcomes (8)

• Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit

  Baseline, Weeks 8, 16 and 24

• Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28

  Weeks 8, 16 and 24

• Swollen and Tender Joint Counts

  Baseline, Weeks 8, 16 and 24

• Physician's Global Assessment of Disease Activity

  Baseline, Weeks 8, 16 and 24

• Participant's Global Assessment of Disease Activity

  Baseline, Weeks 8, 16 and 24

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: methotrexate; Drug: tocilizumab [RoActemra/Actemra]

Interventions

methotrexate DRUG

stable dose as prescribed

Single Arm

tocilizumab [RoActemra/Actemra] DRUG

8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Banja Luka, 78 000, Bosnia and Herzegovina

Location

Unknown Facility

Sarajevo, 71000, Bosnia and Herzegovina

Location

Unknown Facility

Tuzla, 75000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; tocilizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: November 5, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 7, 2014
• Results First Posted: October 20, 2014

Record last verified: 2014-11

Locations

BO (3)