NCT00848120

Brief Summary

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2010

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

January 7, 2015

Completed
Last Updated

August 3, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

February 19, 2009

Results QC Date

May 5, 2014

Last Update Submit

June 28, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24

    ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \[VAS\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.

    Week 24

Secondary Outcomes (8)

  • Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24

    Week 24

  • Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24

    Week 24

  • HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24

    Baseline and Week 24

  • Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24

    Baseline and Week 24

  • Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24

    Baseline and Week 24

  • +3 more secondary outcomes

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients,\>=18 years of age;
  • rheumatoid arthritis diagnosed \>8 weeks and \<4 years prior to baseline;
  • naive to, or not responding well to, methotrexate;
  • swollen joint count \>=8 (66 joint count) and tender joint count\>=8 (68 joint count) at screening and baseline.

You may not qualify if:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • patients with functional class IV rheumatoid arthritis;
  • history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alabang Medical Center

City of Muntinlupa, 1770, Philippines

Location

Manila Doctors Hospital; Rheumatology Section

Manila, 1000, Philippines

Location

Jose Reyes Memorial Medical Center

Manila, 1003, Philippines

Location

Our Lady of Mount Carmel Medical Center

San Fernando City, 2000, Philippines

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

December 31, 2008

Primary Completion

February 13, 2010

Study Completion

February 13, 2010

Last Updated

August 3, 2017

Results First Posted

January 7, 2015

Record last verified: 2017-06

Locations

PH(4)