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OPPOSITE: Open-label, Pilot Protocol of Patients with Rheumatoid Arthritis who Switch to Infliximab after an Incomplete Response To Etanercept - Article


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Infliximab

Remicade



Clinical Trial: OPPOSITE: Open-label, Pilot Protocol of Patients with Rheumatoid Arthritis who Switch to Infliximab after an Incomplete Response To Etanercept

This study has been completed.

Sponsored by: Centocor
Information provided by: Centocor

Purpose

The goals of this multi-center, open-label study for patients with Rheumatoid Arthritis (RA) are: 1. To evaluate safety and evidence of therapeutic benefit of infliximab and methotrexate (MTX). 2. To evaluate pharmacokinetics (PK) of infliximab and etanercept. 3. To evaluate antibodies to infliximab and etanercept. 4. To evaluate whether switching to infliximab alters progression of structural damage over the study period. 5. To evaluate whether candidate serologic markers correlate with therapeutic response or benefit.

Condition Treatment or Intervention Phase
Rheumatoid Arthritis
 Drug: Infliximab
 Drug: Etanercept
Phase III

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Safety/Efficacy Study

Official Title: Open-label, Pilot Protocol of Patients with Rheumatoid Arthritis who Switch to Infliximab after an Incomplete Response To Etanercept

Further Study Details: 

Expected Total Enrollment:  27

Study start: October 2003
Last follow-up: November 2004

1. To evaluate safety and evidence of therapeutic benefit of infliximab and MTX. 2. To evaluate PK of infliximab and etanercept. 3. To evaluate antibodies to infliximab and etanercept. 4. To evaluate whether switching to infliximab alters progression of structural damage over the study period. 5. To evaluate whether candidate serologic markers correlate with therapeutic response or benefit.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Have been receiving background MTX for at least 2 months prior to week –4.
  • Have been receiving a stable etanercept dose of 25 mg subcutaneously twice weekly for at least 2 months prior to week –4.
  • Have shown improvement in signs and symptoms of RA in response to etanercept and MTX according to both the patient and treating physician.
  • Have active disease as defined by both a Tender Joint Count (TJC) > 9 (on the 68 joint set) and a Swollen Joint Count (SJC) > 6 (on the 66 joint set).

Exclusion Criteria:

  • Have had a serious infection, (e.g. hepatitis, pneumonia, or pyelonephritis), have been hospitalized for an infection, or have been treated with IV antibiotics for an infection within 2 weeks prior to week 0. Less serious infections, (e.g. acute upper respiratory tract infection, or simple urinary tract infection), need not be considered exclusions at the discretion of the investigator.
  • Are considered ineligible according to the TB screening, eligibility, assessment, and prevention rules.
  • Are participating in another investigative trial (including registry and observational study) while participating in this trial.

Location Information


California
      UCLA Division of Rheumatology, Dep of Medicine, Los Angeles,  California,  90095-1670,  United States

More Information

Study ID Numbers:  C0168T61
Record last reviewed:  October 2004
Last Updated:  October 19, 2004
Record first received:  October 19, 2004
ClinicalTrials.gov Identifier:  NCT00094471
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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