NCT01010503

Brief Summary

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

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

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

August 13, 2014

Completed
Last Updated

August 13, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

November 9, 2009

Results QC Date

April 8, 2014

Last Update Submit

July 23, 2014

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

  • Percentage of Participants Adherent to Original Treatment

    Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.

    Week 24

  • Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • Percentage of Participants Withdrawing From the Study Prematurely for Any Reason

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg

    Weeks 0, 4, 8, 12, 16, and 20

Secondary Outcomes (10)

  • Disease Activity Score Based on 28-Joint Count (DAS28)

    Weeks 0, 4, 12, and 24

  • Patient Global Assessment of Pain

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • Patient Global Assessment of Disease Activity

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • Physician's Global Assessment of Disease Activity

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • Swollen Joint Count (SJC)

    Weeks 0, 4, 8, 12, 16, 20, and 24

  • +5 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra]DRUG

tocilizumab 8 mg/kg intravenous infusion once in 4 weeks

Single Arm

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 active rheumatoid arthritis
  • inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
  • DAS \>3.6
  • pneumology examination (including chest x-ray and quantiferon)

You may not qualify if:

  • \< 18 years of age
  • active infection
  • active tuberculosis
  • uncontrolled hyperlipoproteinaemia
  • demyelinating disorders
  • concomitant anti-TNF drugs
  • history of intestinal ulceration and diverticulitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Piešťany, 921 12, Slovakia

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

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 10, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 13, 2014

Results First Posted

August 13, 2014

Record last verified: 2014-07

Locations

SL(1)