Long-Term Effects of Infliximab in the Treatment of Moderate to Severe Psoriasis [Extension of Study P04271, NCT00251641] (P04563)

NCT00358670 | Terminated Phase 3 Results DMC

• 2 other identifiers: P04563EUDRACT NUMBER:2005-005367-28
• Study Type: interventional
• Target: 441
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a long-term, randomized, multi-center, open-label study of infliximab treatment in adults with moderate to severe plaque-type psoriasis. This study is the long-term extension of Study P04271 (NCT00251641); Study P04271 is a Phase 3b, randomized, parallel-group, multicenter, open-label, 26-week study comparing the efficacy and safety of infliximab versus methotrexate in the treatment of adult subjects with moderate to severe plaque-type psoriasis. The objectives of this study are to assess the efficacy and safety of long-term maintenance therapy versus intermittent therapy with 5 mg/kg infliximab in a moderate to severe plaque-type psoriasis population. During an interim safety evaluation of the trial, a higher incidence of serious and severe infusion reactions was observed in the intermittent treatment arm, consisting of a re-induction cycle (maximum of 4 infusions at 0, 2, 6 and 14 weeks) after a period of no treatment compared with the maintenance arm (infusions every 8 weeks without an interruption of treatment). Consequently, the sponsor has terminated the trial. The label will be updated to reflect this new information relating to the use of a re-induction regimen with infliximab.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI75) Response at Week 128

  PASI75 defined as the number of participants who achieved a \>=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).

  128 weeks

Secondary Outcomes (4)

• Number of Participants Who Achieved PASI75 Response at Week 52

  52 weeks

• Number of Participants Who Achieved PASI75 Response at Week 100

  100 Weeks

• PASI 6-month Area Under the Curve (AUC); (Time Adjusted Total PASI Score Over the 6 Month Period)

  Day 0 to 180 days

• PASI 12-month AUC (Time Adjusted Total PASI Score Over the 12 Month Period)

  Day 0 to 360 days

Study Arms (2)

Maintenance Infliximab

ACTIVE COMPARATOR

Infliximab 5 mg/kg by body weight every 8 weeks

Biological: infliximab

Intermittent Infliximab

EXPERIMENTAL

Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 Baseline

Biological: infliximab

Interventions

infliximab BIOLOGICAL

Infliximab maintenance therapy intravenous (IV) infusion every 8 weeks, 5 mg/kg body weight (first infusion at Week 4/Visit 2).

Also known as: SCH 215596, Remicade

Maintenance Infliximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects must have been originally randomized to infliximab in Study P04271.
• Subjects must have completed the full 26 weeks of Study P04271.
• Subjects must have remained on infliximab for the full 22 weeks of treatment in Study P04271.
• Subjects must have achieved an improvement in Psoriasis Area and Severity Index (PASI) score \>=75% from Baseline of Study P04271 to Week 26 of Study P04271.
• Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
• Subjects are considered eligible according to the following tuberculosis (TB) criteria:
• Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
• Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication.
• Subjects' Baseline (Visit 1) clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) must be within the following parameters:
• Hemoglobin \>=10 g/dL
• White blood cells \>=3.5 x 10\^9/L
• Neutrophils \>=1.5 x 10\^9/L
• Platelets \>=100 x 10\^9/L
• Serum creatinine \<1.5 mg/dL (or \<133 umol/L)
• Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase levels as outlined in Protocol P04563.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Reich K, Wozel G, Zheng H, van Hoogstraten HJ, Flint L, Barker J. Efficacy and safety of infliximab as continuous or intermittent therapy in patients with moderate-to-severe plaque psoriasis: results of a randomized, long-term extension trial (RESTORE2). Br J Dermatol. 2013 Jun;168(6):1325-34. doi: 10.1111/bjd.12404.

  PMID: 23621698 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharpe & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2006
• First Posted: August 1, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 11, 2017
• Results First Posted: November 19, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share