Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept

NCT00317538 | Completed Phase 3

• 1 other identifier: CR003136
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study, in patients with rheumatoid arthritis who have had an incomplete response to etanercept and methotrexate (MTX), are to evaluate: safety and evidence of therapeutic benefit of infliximab and methotrexate, the levels (pharmacokinetics) of etanercept and infliximab and antibodies (immunogenicity) to etanercept and infliximab in patients blood, whether switching from etanercept to infliximab changes progression of structural damage over the study period, and whether specific markers in the blood (pharmacodynamics) correlate with therapeutic response or benefit.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Switching; Structural Damage; MRI

Outcome Measures

Primary Outcomes (1)

• Evaluate safety and evidence of therapeutic benefit of infliximab and methotrexate, in patients with rheumatoid arthritis who have had an incomplete response to etanercept and methotrexate (MTX), at week 16

Secondary Outcomes (1)

• Evaluate pharmacokinetics, immunogenicity, structural damage and pharmacodynamics over the study period

Interventions

infliximab, etanercept DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have a diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association
• 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
• Must have been using oral or parenteral MTX for the 2 months prior to screening and at a stable dose of 7.5 to 25 mg per week between week -4 and week 0
• Have shown improvement in signs and symptoms of RA in response to etanercept and MTX according to both the patient and the treating physician
• Have active disease as defined by both a TJC of at least 9 (on the 68 joint set) and SJC of at least 6 (on the 66 joint set)
• Have a documented negative reaction to a purified protein derivative (PPD) skin test (PPD induration\< 5 mm) performed within 3 months prior to the week 0 visit

You may not qualify if:

• Patients have been receiving corticosteroids (ie, via any route) at doses \> 10 mg prednisone equivalent daily or have not been taking a stable dose of corticosteroids for at least 1 month prior to week -4
• Have started receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 month of week -4 or have not been on a stable dose of NSAIDs for at least 1 month prior to week -4
• Have received disease modifying anti-rheumatic drugs (DMARDs) or immunosuppressives (except MTX) for at least 1 month prior to week 0
• Patients who have received any prior treatment with infliximab or with any other therapeutic agent targeted at reducing TNF, except etanercept, (e.g.pentoxifylline or thalidomide)
• Patients with a concomitant diagnosis of Congestive Heart Failure, including medically controlled asymptomatic patients
• Any current known malignancy or history of malignancy within the previous 5 years
• Serious infection within the past 3 months or history of chronic infection such as hepatitis, pneumonia, or pyelonephritis in the previous 3 months, any opportunistic infections
• known substance abuse (drug or alcohol) within the previous 3 years
• Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.

Sponsors & Collaborators

• Centocor Ortho Biotech Services, L.L.C.: lead

Related Links

• Open-label, Pilot Protocol of Patients with Rheumatoid Arthritis Who Switch to Infliximab after Incomplete Response to Etanercept

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab; Etanercept

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; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Centocor Ortho Biotech Services, L.L.C. Clinical Trial

  Centocor Ortho Biotech Services, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 25, 2006
• Study Start: June 1, 2003
• Study Completion: November 1, 2004
• Last Updated: May 19, 2011

Record last verified: 2010-04