Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00833053

Purpose

Patients from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan.

While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.

Condition	Intervention	Phase
Psoriasis	Drug: Infliximab Drug: infliximab and methotrexate	Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Methotrexate Infliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

PASI-75 response rate at Week 28. [ Time Frame: At week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PASI-50 response, PASI-90 response, PASI-100 response, and raw PASI scores at Week 28. [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Dermatology Life Quality Index and EQ-5D change from Baseline at Week 28 [ Time Frame: Week 0 and Week 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IFX q 6 weeks: Experimental	Drug: Infliximab Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
IFX + MTX: Experimental	Drug: infliximab and methotrexate Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)

Eligibility

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

Criteria

Inclusion Criteria:

Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
Subjects must be at least 18 years old
Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
Subjects must not be pregnant and must meet contraceptive requirements
Subjects must meet tuberculosis screening criteria
Subjects must meet laboratory and medical history screening requirements

Exclusion Criteria:

Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
Subjects already using certain investigational, biological, or immunosuppressive drugs
Subjects with certain comorbid conditions
Subjects who currently have or have a history of certain infections
Subjects who have recently received live virus or bacterial vaccinations
Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833053

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Canada
Investigational Site 9	Recruiting
Quebec, Canada, G1J 1X7
Investigational Site 10	Recruiting
Montreal, Canada, H3Z 2S6
Investigational Site 12	Recruiting
St. John's, Canada, A1B 4S8
Investigational Site 16	Recruiting
St. John's, Canada, A1B 3E1
Investigational Site 19	Recruiting
Markham, Canada, L3P 1A8
Investigational Site 26	Recruiting
St. John's, Canada, A1B 4S8
Investigational Site 22	Recruiting
Quebec, Canada, G1V 4X7
Investigational Site 23	Recruiting
Oakville, Canada, L6J 7W5
Investigational Site 25	Recruiting
Windsor, Canada, N8W 5L7
Investigational Site 20	Recruiting
Montreal, Canada, H2K 4L5

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05315, EUDRACT: 2008-000454-12
Study First Received:	January 29, 2009
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00833053 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Folic Acid
Antimetabolites
Immunologic Factors
Skin Diseases
Infliximab

Psoriasis
Methotrexate
Antirheumatic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Infliximab
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis
Therapeutic Uses
Abortifacient Agents
Methotrexate
Antirheumatic Agents
Dermatologic Agents
Skin Diseases, Papulosquamous
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 06, 2009