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

NCT00394589 | Terminated Phase 3 Results

• 1 other identifier: P04249
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.

  Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).

  Between Screening (Week <=1) and Week 24

Study Arms (3)

Increased Frequency

EXPERIMENTAL

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

Drug: Infliximab Increased Frequency

Increased Dose

EXPERIMENTAL

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

Drug: Infliximab Increased Dose

Control

ACTIVE COMPARATOR

Continuation of infliximab 3 mg/kg every 8 weeks

Drug: Infliximab Control

Interventions

Infliximab Increased Frequency DRUG

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

Also known as: Increased Frequency

Increased Frequency

Infliximab Increased Dose DRUG

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

Also known as: Increased Dose

Increased Dose

Infliximab Control DRUG

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

Also known as: Control

Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Integrated Therapeutics Group: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 11, 2017
• Results First Posted: January 21, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share