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A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)(COMPLETED) (REQUEST)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00741104
First received: July 30, 2008
Last updated: September 24, 2009
Last verified: September 2009
History of Changes
  Purpose

This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.


Condition Intervention
Rheumatoid Arthritis
 Drug: Infliximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients

Resource links provided by NLM:

Drug Information available for: Infliximab
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Dosing Interval Between the Infliximab Infusions [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ] [ Designated as safety issue: No ]
  • Reason for Extending Dosing Interval [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ] [ Designated as safety issue: No ]
  • Patient Response to Increased Dosing Interval [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ] [ Designated as safety issue: No ]
  • Number of Patients Agreeing to Participate in a Dose Reduction Study [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage. [ Time Frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) [ Time Frame: Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry. ] [ Designated as safety issue: Yes ]
  • Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire. [ Time Frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. ] [ Designated as safety issue: No ]

Enrollment: 363
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RA patients
Patients on maintenance therapy for RA with infliximab for >= the past 12 months.
 Drug: Infliximab
Treatment of RA with Infliximab according to and under normal routine clinical practice.
Other Names:
  • Remicade
  • SCH 215596

Detailed Description:

Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects are Swedish patients on maintenance therapy for RA with infliximab for >= the past 12 months.

Criteria

Inclusion Criteria:

  • Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.

Exclusion Criteria:

  • episodic treatment with infliximab
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00741104     History of Changes
Other Study ID Numbers: P05417
Study First Received: July 30, 2008
Results First Received: June 11, 2009
Last Updated: September 24, 2009
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013