A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)

NCT00686595 | Completed Phase 4 Results DMC

• 2 other identifiers: P051332007-000535-26
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy, tolerability, and effect on the quality of life of infliximab in adults with moderate-to-severe psoriasis who are resistant to etanercept after 12 weeks of treatment or have failed 24 weeks of treatment with etanercept. Infliximab will be administered as an intravenous infusion of 5 mg/kg at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10

  PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.

  Baseline and 10 weeks

Secondary Outcomes (21)

• PASI 75 Response Rate at Week 18

  Baseline and 18 weeks

• PASI 75 Response Rate at Week 24

  Baseline and 24 weeks

• PASI 50 Response Rate at Week 10

  Baseline and 10 weeks

• PASI 50 Response Rate at Week 18

  Baseline and 18 weeks

• PASI 50 Response Rate at Week 24

  Baseline and 24 weeks

Study Arms (1)

Infliximab 5 mg/kg

EXPERIMENTAL

Infliximab 5 mg/kg intravenous (IV) infusion administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

Infliximab 5 mg/kg IV infusion.

Also known as: Remicade, SCH 215596

Infliximab 5 mg/kg

Eligibility Criteria

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

You may qualify if:

• \>=18 to 75 years of age at Screening, either sex, and any race.
• Diagnosis of moderate-to-severe plaque psoriasis \>6 months prior to Screening.
• Resistant (after 12 weeks) or failed 24 weeks of etanercept treatment.
• Not reached PASI 75 at Screening Visit after 24 weeks of etanercept treatment or resistant to etanercept.
• Agree to avoid prolonged sun exposure or artificial ultraviolet light sources during study.
• Satisfy requirements of Screening and tuberculosis (TB) test as specified in protocol.
• Chest x-ray at Visit 1 or within 3 months prior to Visit 1 with no evidence of malignancy, infection, or fibrosis.
• Laboratory tests must be within protocol-specified parameters.
• Free of any clinically significant disease that would interfere with study evaluations.
• Willing to participate and adhere to study procedures by signing written informed consent.
• Women of childbearing potential and all men must be using adequate birth control measures and continue to do so until 6 months after receiving last dose of study medication.
• Females of childbearing potential must have negative serum pregnancy test at Visit 1 and negative urine pregnancy test at Visit 2.

You may not qualify if:

• Achieve PASI 75 or have BSA \<10% after 24 weeks of etanercept.
• Current drug-induced psoriasis.
• Females who are pregnant or nursing and both males and females who are planning pregnancy during study period or during 6 months after receiving last dose of study medication.
• Previously treated with infliximab.
• Currently taking or have taken protocol-specified prohibited drugs within specified time frame prior to Baseline.
• Congestive Heart Failure (CHF)
• Chronic or recurrent infectious disease.
• Have or have had serious infection, or been hospitalized or received IV antibiotics for this infection during the 2 months prior to Visit 1.
• Have or have had opportunistic infection within 6 months prior to Visit 1.
• Have or have had herpes zoster infection within 2 months prior to Visit 1.
• Human Immunodeficiency Virus (HIV), hepatitis B or C.
• History of any clinically significant adverse events (AEs) to murine or chimeric proteins or human/murine recombinant products.
• Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
• History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
• Current signs and symptoms or history of systemic lupus erythematosus.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

Related Publications (1)

• Ayala F, Lambert J; TANGO Study Group. Efficacy, tolerability and safety of switching from etanercept to infliximab for the treatment of moderate-to-severe psoriasis: A multicenter, open-label trial (TANGO). J Dermatolog Treat. 2015;26(4):304-11. doi: 10.3109/09546634.2014.952611. Epub 2014 Sep 18.

  PMID: 25231176 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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 9, 2023
• Results First Posted: February 24, 2011

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share