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

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Infliximab Control Drug: Infliximab Increased Frequency Drug: Infliximab	Phase III

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Infliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score. [ Time Frame: Between Screening (Week <=1) and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other measures and sub-measures of disease activity. [ Time Frame: Between Screening (Week <=1) and Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	315
Study Start Date:	March 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Active Comparator Continuation of Infliximab 3 mg/kg every 8 weeks	Drug: Infliximab Control Continue infliximab 3 mg/kg every 8 weeks for 24 weeks
Increased Frequency: Experimental Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks	Drug: Infliximab Increased Frequency Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks
Increased Dose: Experimental 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks	Drug: Infliximab 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients were excluded if they met any of the following 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; has used any investigational medical product within 30 days prior to Baseline; has 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; has rheumatic disease other than RA or has any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity; or has an allergic reaction/sensitivity to the study drug or its excipients that requires corticosteroid pre-infusion medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394589

Show 51 Study Locations

Sponsors and Collaborators

Schering-Plough

Integrated Therapeutics Group

Investigators


Study Chair:	Maarten Kraan, MD, PhD	SP GMA Senior Medical Director, Immunology

More Information

Responsible Party:	Schering-Plough ( Maarten Kraan, PhD - Senior Global Medical Director, Global Medical Affairs )
Study ID Numbers:	P04249
First Received:	October 31, 2006
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00394589
Health Authority:	Austria: Federal Ministry for Health and Women; Belgium: Ministry of Social Affairs, Public Health and the Environment; Denmark: Danish Medicines Agency; France: Ministry of Health; Germany: Paul-Ehrlich-Institut; Greece: Ministry of Health and Welfare; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Portugal: National Pharmacy and Medicines Institute; Sweden: Medical Products Agency; Turkey: Ministry of Health

Study placed in the following topic categories:

Autoimmune Diseases

Musculoskeletal Diseases

Infliximab

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immune System Diseases

Therapeutic Uses

Gastrointestinal Agents

Antirheumatic Agents

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	Schering-Plough Integrated Therapeutics Group
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00394589