Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)

NCT ID: NCT00394589

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-10-31

Brief Summary

This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity.

Subjects responding to an initial infliximab treatment regimen, who flare during continuation of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks. The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded. The increased frequency group is not blinded. Clinical assessments of disease activity will be based the European League Against Rheumatism (EULAR) criteria for response. Safety parameters will be assessed at every infusion.

A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when compared to the DAS28 score measured immediately prior to the last Remicade® infusion and depends upon the actual score as well. Since prior to enrollment, the subject received Remicade® as per routine clinical practice, the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2, 6 and 14.

• Drug: Infliximab Control (double-blinded)
• Drug: Infliximab Increased Dose (double-blinded)
• Drug: Infliximab Increased Frequency (open-label)

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Increased Frequency

Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks

Group Type: EXPERIMENTAL

Infliximab Increased Frequency

Intervention Type: DRUG

Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks

Increased Dose

3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks

Group Type: EXPERIMENTAL

Infliximab Increased Dose

Intervention Type: DRUG

3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks

Control

Continuation of infliximab 3 mg/kg every 8 weeks

Group Type: ACTIVE_COMPARATOR

Infliximab Control

Intervention Type: DRUG

Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks

Interventions

Infliximab Increased Frequency

Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks

Intervention Type: DRUG

Infliximab Increased Dose

3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks

Intervention Type: DRUG

Infliximab Control

Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks

Intervention Type: DRUG

Other Intervention Names

Increased Frequency; Increased Dose; Control

Eligibility Criteria

Inclusion Criteria

• aged 18 years or more
• with RA according to ACR criteria
• presented with a disease flare after initial response to infliximab, with both response and flare being defined using the DAS28 score (EULAR criteria)
• received the standard Remicade® dosing schedule per the EU label (3 mg/kg at Weeks 0, 2, 6, [and 14])
• an initial response documented by moderate or good DAS28 improvement (EULAR criteria) from Week 0 to Week 6 or 14.

Exclusion Criteria

• a female who is, or intends to become, pregnant during or within 6 months of the end of the study, is nursing or not using adequate contraceptive measures
• has not observed the designated periods for concomitant medications
• used any investigational medical product within 30 days prior to Baseline
• any clinically significant deviation from normal in the physical examination or chest X-ray that in the investigator's judgment, may interfere with the study evaluation or affect subject safety
• rheumatic disease other than RA or has any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity
• allergic reaction/sensitivity to the study drug or its excipients that requires corticosteroid pre-infusion medication.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integrated Therapeutics Group

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04249

Identifier Type: -

Identifier Source: org_study_id