PsoriasisPhase 4TANGONCT00686595

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

A Phase 4 study testing Infliximab in people with Psoriasis, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Psoriasis
What is being tested?: Infliximab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: 1 Oct 2007to 1 Oct 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

>=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.

Show all 12Show fewer

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.

Who cannot join

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)

Show all 26Show fewer

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.

About this study

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)

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
Being tested: Infliximab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InfliximabBiological
Also called Remicade, SCH 215596
Infliximab 5 mg/kg IV infusion.

Study groups in NCT00686595
Study group	Role	What they receive
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). Receives: Biological: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 10 weeks

Secondary outcomes (21)

PASI 75 Response Rate at Week 18
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.
Measured: Baseline and 18 weeks
PASI 75 Response Rate at Week 24
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.
Measured: Baseline and 24 weeks
PASI 50 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 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.
Measured: Baseline and 10 weeks
PASI 50 Response Rate at Week 18
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.
Measured: Baseline and 18 weeks
PASI 50 Response Rate at Week 24
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.
Measured: Baseline and 24 weeks
PASI 90 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 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.
Measured: Baseline and 10 weeks
PASI 90 Response Rate at Week 18
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.
Measured: Baseline and 18 weeks
PASI 90 Response Rate at Week 24
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
Measured: Baseline and 24 weeks
PASI 100 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 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.
Measured: Baseline and 10 weeks
PASI 100 Response Rate at Week 18
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.
Measured: Baseline and 18 weeks
PASI 100 Response Rate at Week 24
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.
Measured: 24 weeks
Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18
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.
Measured: Baseline and Week 18
Percent Reduction in SAPASI at Week 24
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.
Measured: Baseline and Week 24
Percent Reduction in Affected Body Surface Area (BSA) at Week 18
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.
Measured: Baseline and Week 18
Percent Reduction in Affected BSA at Week 24
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.
Measured: Baseline and Week 24
Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18
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.
Measured: Baseline and Week 18
Percent Reduction in VAS Referred Itch at Week 24
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.
Measured: Baseline and Week 24
Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18
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.
Measured: Baseline and Week 18
Percent Reduction in DLQI Total Score at Week 24
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.
Measured: Baseline and Week 24
Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18
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.
Measured: Baseline and Week 18
Percent Reduction in SKINDEX-29 Scores at Week 24
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.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20071 Oct 2009

First posted30 May 2008 (estimated)
Study start1 Oct 2007
Primary completion1 Oct 2009
Study completion1 Oct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00686595
Sponsor's protocol ID: P05133
Other IDs: 2007-000535-26
Acronym: TANGO
Status last verified: Jul 2023
First submitted: 27 May 2008
Last updated: 9 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

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.
PubMed 25231176

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00686595
Acronym / sponsor ID: TANGO / P05133
Conditions: Psoriasis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Centocor, Inc.
Study start: 1 Oct 2007 (actual)
Primary completion: 1 Oct 2009 (actual)
Study completion: 1 Oct 2009 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 24 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Infliximab 5 mg/kg	Experimental	Biological: InfliximabInfliximab 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).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

>=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.

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InfliximabAlso: Remicade, SCH 215596Infliximab 5 mg/kg IV infusion.	Biological	Infliximab 5 mg/kg

Primary outcome

Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10
Time frame: Baseline and 10 weeks
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.

21 secondary outcomes

PASI 75 Response Rate at Week 18
Time frame: Baseline and 18 weeks
PASI 75 Response Rate at Week 24
Time frame: Baseline and 24 weeks
PASI 50 Response Rate at Week 10
Time frame: Baseline and 10 weeks
PASI 50 Response Rate at Week 18
Time frame: Baseline and 18 weeks
PASI 50 Response Rate at Week 24
Time frame: Baseline and 24 weeks
PASI 90 Response Rate at Week 10
Time frame: Baseline and 10 weeks
PASI 90 Response Rate at Week 18
Time frame: Baseline and 18 weeks
PASI 90 Response Rate at Week 24
Time frame: Baseline and 24 weeks
PASI 100 Response Rate at Week 10
Time frame: Baseline and 10 weeks
PASI 100 Response Rate at Week 18
Time frame: Baseline and 18 weeks
PASI 100 Response Rate at Week 24
Time frame: 24 weeks
Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18
Time frame: Baseline and Week 18
Percent Reduction in SAPASI at Week 24
Time frame: Baseline and Week 24
Percent Reduction in Affected Body Surface Area (BSA) at Week 18
Time frame: Baseline and Week 18
Percent Reduction in Affected BSA at Week 24
Time frame: Baseline and Week 24
Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18
Time frame: Baseline and Week 18
Percent Reduction in VAS Referred Itch at Week 24
Time frame: Baseline and Week 24
Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18
Time frame: Baseline and Week 18
Percent Reduction in DLQI Total Score at Week 24
Time frame: Baseline and Week 24
Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18
Time frame: Baseline and Week 18
Percent Reduction in SKINDEX-29 Scores at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 24 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infliximab 5 mg/kg	38	31

Primary outcome: Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10

Time frame: Baseline and 10 weeks. Number. Unit: Percentage of participants

Measure	Infliximab 5 mg/kg n = 35
Value	71

Population analysed: Participants from the intent-to-treat (ITT) population for whom the PASI assessment was available.

21 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infliximab 5 mg/kg	7 of 38 (18.4%)	12 of 38 (31.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25231176Ayala 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.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Infliximab in people with Psoriasis, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10 (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00686595, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.