NCT01089023

Brief Summary

This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab \[RoActemra/Actemra\] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jan 2010

Geographic Reach
5 countries

9 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

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

March 8, 2010

Results QC Date

June 23, 2014

Last Update Submit

June 23, 2014

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events

    Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.

    Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24

Secondary Outcomes (8)

  • Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category

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

  • Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28

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

  • Time to DAS28 Response by DAS28 Category

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

  • Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units

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

  • Percentage of Participants With Improvement in Physical Function by HAQ-DI Category

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

  • +3 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra]DRUG

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

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
  • moderate to severe rheumatoid arthritis (DAS28 \>3.2) of 6 months duration
  • inadequate clinical response to non-biologic DMARDs or anti-TNF
  • bodyweight \</=150 kg

You may not qualify if:

  • rheumatic autoimmune disease or inflammatory joint disease other than RA
  • major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Manama, 12, Bahrain

Location

Unknown Facility

Riffa, 28743, Bahrain

Location

Unknown Facility

Isfahan, 8174675731, Iran

Location

Unknown Facility

Tehran, 1333631151, Iran

Location

Unknown Facility

Tehran, 14114, Iran

Location

Unknown Facility

Safat, 13041, Kuwait

Location

Unknown Facility

Doha, 3050, Qatar

Location

Unknown Facility

Abu Dhabi, 51900, United Arab Emirates

Location

Unknown Facility

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 18, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 22, 2014

Results First Posted

July 22, 2014

Record last verified: 2014-06

Locations

BA(2)IR(3)QA(1)AE(2)KU(1)