A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

NCT01245439 | Completed Phase 3 Results

• 1 other identifier: ML25095
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 17

Brief Summary

This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events

  An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.

  24 weeks

Secondary Outcomes (27)

• Percentage of Participants With All-Cause Discontinuation

  24 weeks

• Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN

  Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)

• Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN

  Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)

• Percentage of Participants With Serious Infections

  Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)

• Number of Participants With Serious Infections

  Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)

Study Arms (1)

1

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions

1

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
• Moderate to severe active rheumatoid arthritis (DAS28\>/=3.2) of \>/=6 months duration
• Body weight \</=150 kg
• Patients are on one or more non-biologic DMARDs at a stable dose for a period \>/=8 weeks prior to study treatment
• Patients with inadequate clinical response to a stable dose of non-biologic DMARD

You may not qualify if:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
• Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
• History of or current inflammatory joint disease other than rheumatoid arthritis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Unknown Facility

Adana, 01330, Turkey (Türkiye)

Location

Unknown Facility

Ankara, 06100, Turkey (Türkiye)

Location

Unknown Facility

Ankara, 06500, Turkey (Türkiye)

Location

Unknown Facility

Aydin, 09100, Turkey (Türkiye)

Location

Unknown Facility

Bursa, 16059, Turkey (Türkiye)

Location

Unknown Facility

Denizli, 20020, Turkey (Türkiye)

Location

Unknown Facility

Elâzığ, 23119, Turkey (Türkiye)

Location

Unknown Facility

Gaziantep, 27310, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34000, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 35100, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 35170, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 54100, Turkey (Türkiye)

Location

Unknown Facility

İzmit, 41380, Turkey (Türkiye)

Location

Unknown Facility

Konya, 42080, Turkey (Türkiye)

Location

Unknown Facility

Manisa, 45200, Turkey (Türkiye)

Location

Unknown Facility

Samsun, 55139, Turkey (Türkiye)

Location

Unknown Facility

Sivas, 58140, Turkey (Türkiye)

Location

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: Hoffmannb-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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 22, 2010
• Study Start: September 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 3, 2015
• Results First Posted: November 3, 2015

Record last verified: 2015-10

Locations

TU (17)