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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686595
First received: May 27, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Psoriasis
Biological: Infliximab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: swiTching From etAnercept to iNfliximab in the Treatment of Moderate to Severe Psoriasis; a Multi-center, Open Label Trial evaluatinG the Efficacy, tOlerance and Safety (TANGO)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • PASI 75 Response Rate at Week 18 [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
    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 18 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 18.

  • PASI 75 Response Rate at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 24 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 24.

  • PASI 50 Response Rate at Week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    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 50 response rate at Week 10 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 10.

  • PASI 50 Response Rate at Week 18 [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
    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 50 response rate at Week 18 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 18.

  • PASI 50 Response Rate at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 50 response rate at Week 24 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 24.

  • PASI 90 Response Rate at Week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    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 90 response rate at Week 10 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 10.

  • PASI 90 Response Rate at Week 18 [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
    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 90 response rate at Week 18 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 18.

  • PASI 90 Response Rate at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 90 response rate at Week 24 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 24.in PASI at Week 24

  • PASI 100 Response Rate at Week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    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 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.

  • PASI 100 Response Rate at Week 18 [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
    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 100 response rate at Week 18 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 18.

  • PASI 100 Response Rate at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 100 response rate at Week 24 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 24.

  • Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 18 compared to baseline is reported.

  • Percent Reduction in SAPASI at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 24 compared to baseline is reported.

  • Percent Reduction in Affected Body Surface Area (BSA) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant's body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 18 compared to baseline is reported.

  • Percent Reduction in Affected BSA at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant's body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 24 compared to baseline is reported.

  • Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 18 compared to baseline is reported.

  • Percent Reduction in VAS Referred Itch at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 24 compared to baseline is reported.

  • Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 18 compared to baseline is reported.

  • Percent Reduction in DLQI Total Score at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 24 compared to baseline is reported.

  • Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from "never" (=0) to "all the time" (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 18 compared to baseline is reported.

  • Percent Reduction in SKINDEX-29 Scores at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from "never" (=0) to "all the time" (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 24 compared to baseline is reported.


Enrollment: 48
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infliximab 5 mg/kg
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
Infliximab 5 mg/kg IV infusion.
Other Name: Remicade, SCH 215596

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >=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.

Exclusion Criteria:

  • 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.
  • Transplanted organ (exception - corneal transplant >3 months prior to Visit 1).
  • History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.
  • Malignancy within previous 5 years (exception - basal cell carcinoma of skin that has been treated with no evidence of recurrence).
  • Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
  • Have had substance abuse (drug or alcohol) problem within previous 3 years.
  • History of any clinically significant adverse reactions (including allergic reactions) to paracetamol/acetaminophen or histamine H1 receptor antagonist.
  • In a situation or have a condition that, in opinion of investigator, may interfere with optimal participation in study.
  • Used investigational drugs within 4 weeks of Screening.
  • Participating in any other clinical study.
  • Staff personnel directly involved with this study.
  • Family members of investigational study staff.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686595     History of Changes
Other Study ID Numbers: P05133
Study First Received: May 27, 2008
Results First Received: January 27, 2011
Last Updated: December 17, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 24, 2014