Reflections B537-02

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-060-14
• Date of registration: 28/05/2015
• Prospective Registration: No
• Primary sponsor: Pfizer Inc.,
• Public title: Reflections B537-02
• Scientific title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
• Date of first enrolment: 06/03/2015
• Target sample size: 32
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=060-14
• Study type: Interventional
• Study design: This is a Phase 3, multi-national, randomized, double blind, two-arm, parallel group study designed to evaluate the safety, efficacy, and immunogenicity of infliximab-Pfizer versus infliximab-EU in combination with methotrexate when administered intravenously to treat subjects with moderately to severely active RA who have had an inadequate response to methotrexate therapy. This study is also designed to evaluate clinical response, safety and immunogenicity after study drug transitioning from infliximab-EU to infliximab-Pfizer after 6 or 12 months of infliximab-EU treatment. Clinical and laboratory measures including joint counts, patients and physician’s global assessment of arthritis and arthritis pain using Visual. Analog Scales (VAS), HAQ-DI, laboratory tests, etc will be used as the basis for assessments of clinical improvement (eg, ACR and DAS responses). The primary endpoint is ACR20 response at Week 14 of study treatment. Upon completion of Screening, eligible subject
• Phase: III

Countries of recruitment

Arabia Saudi, Argentina, Australia, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Georgia, Germany, Guatemala, Hungary, Israel, Japan, Jordan, Korea South, Lithuania, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Tunisia, Ukraine, United Kindgdom, United States

Key inclusion & exclusion criteria

Inclusion criteria: 1. signed and dated informed consent document .2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.3. Male and female subjects aged 18 years or older at the time of informed consent. 4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 6 months after the last dose of assigned treatment.5. Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (see Appendix 1) for RA for at least a 4 month duration.6. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA 7. Moderately to severely active RA disease as defined by the following criteria: ( see the protocol).8. Stable dose of oral or parenteral methotrexate of 10 to 25 mg/week. Subjects who cannot tolerate 10 to 25 mg/week methotrexate may take a lower dose of as low as7.5 mg/week (as low as 6 mg/week in geographic regions where specified by local guidance). Subjects must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks prior to first dose of study drug. 9. Stable dose of oral folic (at least 1 mg/day on ≥5 days/week) or folinic acid (≥5 mg once per week) supplementation for at least 21 days prior to the first dose of study drug. FOR MORE DETAILS SEE THE PROTOCOL
Exclusion criteria:
1.Pregnant females and breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after last dose of investigational product.2. Clinically significant laboratory abnormalities at Screening,: a. Hemoglobin (Hgb) <9 g/dL.b. Absolute neutrophil count (ANC) ≤ 1500 cells/mm3.c. White blood cell count <3.0 x 109/L. d. Platelets <100 x 109/L. e. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 2 times theupper limit of normal. f. Bilirubin ≥ 1.5 times the upper limit of normal. g. Serum creatinine ≥ 1.5 mg/dL. Subjects who do not meet a lab entry criteria but satisfy all other study entry criteria may have the lab re-tested within 14 days and, if within the required range, will be eligible to enroll into the study provided all other inclusion/exclusion criteria are met. 3. Evidence or history of moderate or severe heart failure .4. Evidence of current or recent history of uncontrolled, clinically significant infectious,hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. 5. Evidence or history of seizures, or nervous system demyelinating diseases 6.Evidence or history of a malignancy within the past 5 years with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ with no evidence of recurrence. FOR MORE DETAILS SEE THE PROTOCOL


Age minimum: 18
Age maximum: 90
Gender: --

Health Condition(s) or Problem(s) studied

-M05

M05

Intervention(s)

subjects will start their infliximab treatment with a uniform dose regimen, which is an intravenous infusion at a dose of 3 mg/kg , followed by a maintenance regimen of every 8 weeks. The dose will remain consistent (up to Week 14). A one-time dose escalation may begin with a dose increase to 5 mg/kg every 8 weeks. Subjects who fail to achieve a minimal response by Week 30 (including dose escalation) will be discontinued from further study treatment. Treatment Period 2 will begin with the dosing on Week 30, when subjects from the infliximab-EU arm will be re-randomized with 50% switching to infliximab-Pfizer and the other 50% remaining on infliximab-EU.treatment Period 3 will begin with the Week 54 dosing, when any subjects remaining on infliximab-EU will be switched to infliximab-Pfizer. All subjects will continue to receive infliximab-Pfizer treatment for an additional 24 weeks, with last study drug dosing scheduled on Week 70, and the end of treatment (EOT) visit on Week 78.Subjects are required to continue their stable background regimen of oral or parenteral methotrexate (10 to 25 mg/week; or as low as 7.5 mg/week for intolerant subjects) throughout the study. PF-06438179 (infliximab-Pfizer) and infliximab-EU will be supplied by the Sponsor as sterile lyophilized powder containing 100 mg of infliximab.

Source(s) of Monetary Support

Pfizer Inc.

Ethics review

Status: Approved
Approval date: 17/07/2014
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 04/08/2014
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 14/08/2014
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 18/08/2014
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 06/11/2014
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 13/11/2014
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 17/12/2014
Contact:

[e-mail]

Clinica Anglo Americana

6168900

[e-mail]