NCT01187563

Brief Summary

This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

2 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

August 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

4 months

First QC Date

August 23, 2010

Last Update Submit

October 12, 2011

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, tocilizumab

Outcome Measures

Primary Outcomes (1)

  • Safety (clinical and laboratory parameters)

    Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count

    Throughout the study until week 10

Secondary Outcomes (1)

  • Treatment emergent adverse events

    Throughout the study until week 10

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult rheumatoid arthritis patients with indication for treatment with tocilizumab.

You may qualify if:

  • ≥ 18 years of age
  • Moderately to severely active rheumatoid arthritis
  • Inadequate response to previous treatment with an anti-TNF agent
  • Receiving methotrexate for at least 12 wks before study

You may not qualify if:

  • Previous treatment with tocilizumab
  • Previous treatment with other IL-6 receptor inhibitors
  • Treatment with corticosteroids (oral prednisone \>10 mg/day or equivalent) within 4 wks
  • Conditions noted in the tocilizumab prescribing information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

US(2)