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

NCT00741104 | Completed Results

• 1 other identifier: P05417
• Study Type: observational
• Target: 363
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Dosing Interval Between the Infliximab Infusions

  Patients were asked as part of the Remicade questionnaire what dosing interval they were on.

  Measured from the Remicade Questionnaire at first (and only) study visit

• Reason for Extending Dosing Interval

  Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.

  Measured from the Remicade Questionnaire at first (and only) study visit

• Patient Response to Increased Dosing Interval

  Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?" Those who noticed a difference were asked if their experience was positive or negative.

  Measured from the Remicade Questionnaire at first (and only) study visit

• Number of Patients Agreeing to Participate in a Dose Reduction Study

  As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"

  Measured from the Remicade Questionnaire at first (and only) study visit

Secondary Outcomes (3)

• Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.

  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.

• Adverse Events (AEs)

  Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.

• Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.

  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.

Study Arms (1)

RA patients

Patients on maintenance therapy for RA with infliximab for \>= the past 12 months.

Drug: Infliximab

Interventions

Infliximab DRUG

Treatment of RA with Infliximab according to and under normal routine clinical practice.

Also known as: Remicade, SCH 215596

RA patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• episodic treatment with infliximab

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.

  PMID: 21407184 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 26, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 4, 2017
• Results First Posted: August 21, 2009

Record last verified: 2017-01