A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

NCT00773461 | Completed Phase 3 Results

• 1 other identifier: ML21753
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 9

Brief Summary

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24

  To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward \[LOCF\]).

  Week 24

Secondary Outcomes (16)

• Percentage of Participants With ACR50 and ACR70 Responses at Week 24

  Week 24

• Number of Participants Who Received Escape Therapy

  24 Weeks

• Change in Tender and Swollen Joint Counts From Baseline to Week 24

  Baseline and Week 24

• Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24

  Baseline and Week 24

• Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24

  Baseline and Week 24

Study Arms (2)

1

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8mg/kg iv every 4 weeks for 24 weeks

1

Placebo DRUG

iv every 4 weeks for 24 weeks

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18-70 years of age;
• rheumatoid arthritis for \>= 6 months;
• receiving permitted DMARDs, at a stable dose, for \>= 8 weeks prior to baseline;
• current inadequate clinical response to DMARDs.

You may not qualify if:

• major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
• rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
• unsuccessful treatment with an anti-TNF agent;
• previous treatment with tocilizumab.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Union Hospital

Beijing, 100730, China

Location

General Hospital of Chinese PLA; Department of Hematology

Beijing, 100853, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510630, China

Location

The 1st Affiliated Hospital of Harbin Medical University

Harbin, 150001, China

Location

Qilu Hospital of Shandong University

Jinan, 250012, China

Location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

Changhai Hospital of Shanghai

Shanghai, 200433, China

Location

The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

Xi'an, 710032, China

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- LaRoche

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 31, 2008
• Primary Completion: July 22, 2010
• Study Completion: July 22, 2010
• Last Updated: August 1, 2017
• Results First Posted: July 21, 2016

Record last verified: 2017-06

Locations

CN (9)