NCT00725621

Brief Summary

This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
516

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

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

March 1, 2004

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 4, 2011

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

6.3 years

First QC Date

July 25, 2008

Results QC Date

July 8, 2011

Last Update Submit

September 2, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

  • Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

    Maximum of 16 weeks

  • Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

    Maximum of 16 weeks

  • Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

    Maximum of 102 weeks

  • Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

    Maximum of 102 weeks

  • Mean Remicade Dose Per Participant

    Maximum of 102 weeks

  • Median Remicade Dose Per Participant

    Maximum of 102 weeks

Secondary Outcomes (4)

  • Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy

    24 months maximum

  • Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

    24 months maximum

  • Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)

    24 months maximum

  • Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS

    24 months maximum

Study Arms (1)

Remicade

Patients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians.

Biological: Infliximab

Interventions

InfliximabBIOLOGICAL

Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians.

Also known as: Remicade, SCH 215596
Remicade

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe RA being treated at specialized centers.

You may qualify if:

  • Severe RA (indication according to Austrian labeling).

You may not qualify if:

  • According to Summary of Product Characteristics (SPC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 30, 2008

Study Start

March 1, 2004

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 3, 2015

Results First Posted

August 4, 2011

Record last verified: 2015-09