A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

NCT00810277 | Completed Phase 3 Results

• 2 other identifiers: ML220122008-004126-16
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. AEs included both serious as well as non-serious AEs.

  Baseline up to Week 24

Secondary Outcomes (9)

• Disease Activity Score (DAS28)

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

• Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)

  Weeks 4, 8, 12, 16, 20, and 24

• Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response

  Weeks 4, 8, 12, 16, 20, and 24

• C-Reactive Protein (CRP) Level

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

• Erythrocyte Sedimentation Rate (ESR)

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

Study Arms (1)

1

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8mg/kg iv every 4 weeks for 24 weeks

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 rheumatoid arthritis;
• inadequate response to current non-biologic DMARDs

You may not qualify if:

• rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
• previous treatment with other biologics.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Kanta-Hämeen Keskussairaala ; Reumatologia

Hämeenlinna, 13530, Finland

Location

Kiljavan Lääketutkimus Oy

Hyvinkää, 05800, Finland

Location

Kanta-Hämeen keskussairaala; Riihimäen aluesairaala Reumapoliklinikka

Riihimäki, 11101, Finland

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: Hoffmann-La Roche

genentech@druginfo.com

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: December 16, 2008
• First Posted: December 18, 2008
• Study Start: November 30, 2008
• Primary Completion: May 26, 2010
• Study Completion: May 26, 2010
• Last Updated: August 3, 2017
• Results First Posted: March 31, 2016

Record last verified: 2017-06

Locations

FI (3)