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) - TANGO

• Conditions: moderate to severe psoriasis that are resistent to etanercept ab initio or have failed 24 weeks of treatment with etanercept; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2007-000535-26-BE
• Lead Sponsor: Schering Plough S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-29
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subjects must be =18 to 75 years of age at Screening, of either sex, and of any race.

2. Subjects must have had a diagnosis of moderate to severe plaque psoriasis at least 6 months prior to Screening (subjects with concurrent psoriatic arthritis may be enrolled).

3. Subjects resistant or patient who must have failed 24 weeks of treatment with etanercept. (Definition of resistant patient: patient who has not modified or presents an increase in his PASI score or BSA affected after 12 weeks of etanercept treatment. Definition of patient failure: patient who has not reached PASI 75 or presents BSA = 10 at Screening visit (V1) after 24 weeks of etanercept treatment.

4. Subjects who has not reached PASI 75 at Screening visit (V1) after 24 weeks of etanercept treatment or resistant ab initio to etanercept.

5. Subjects must agree to avoid prolonged sun exposure or artificial ultraviolet light sources during the study.

6. Subjects must comply with the requirements of the screening and diagnosis Tubercolosis Skin Test (according to procedure described in section 8.12 of the present protocol).
Subjects are considered eligible according to the following criteria:

a. Have no history of latent or active TB prior to screening;

b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;

c. 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;

d. Two negative tuberculin skin tests; one positive tuberculin skin test in association with appropriate treatment for latent TB initiated prior to or simultaneously with the first administration of study medication

7. Subjects must have had a chest x-ray (posterior-anterior and lateral) at visit 1 or within 3 months prior to vist 1 with no evidence of malignancy, infection or fibrosis.

8. Subjects’ Screening clinical laboratory tests must be within the following parameters:

a. Hemoglobin =10 g/dL
b. White blood cells =3.5 x 109/L
c. Neutrophils =1.5 x 109/L
d. Platelets =100 x 109/L
e. Serum creatinine <1.5 mg/dL
f. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase =1.5 x upper limit of normal range
g. Total bilirubin =1.5 x upper limit of normal range

9. Subjects must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that would interfere with the study evaluations.

10. Subjects must be willing to participate to the study and to adhere to study procedures by signing the written informed consent.

11. Women of childbearing potential and all men must be using adequate birth control measures and must continue using such measures until 6 months after receiving the last dose of study medication.

12. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at visit 1 and a negative urine pregnancy test at visit 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who achieved PASI 75 or who have had BSA < 10 after 24 weeks of etanercept treatment.

2. Subjects who have current drug-induced psoriasis (f.i., a new onset of psoriasis or an exacerbation of psoriasis due to iatrogenic factors).

3. Female subjects who are pregnant, nursing, and both men and women who are planning pregnancy during the study period or during the 6 months after receiving the last dose of study medication.

4. Subjects previously treated with infliximab.

5. Subjects who are currently taking or have taken the following drugs within the specified time frame prior to Screening (see Section 6.2):

a. any live or attenuated virus or bacterial vaccinations received within 3 months prior to visit 1

b. any systemic medications/treatments that could affect psoriasis or clinical evaluations within 4 weeks prior to visit 1.

c. lithium within 4 weeks prior to visit 1

d. any topical medications/treatments that could affect psoriasis or PASI evaluations within 2 weeks prior to visit 1. The only allowed treatments are emollient/moisturizing lotion and shampoos containing salicylic acid. Subjects should not use these topical agents the day prior to study visit. Non-medicated shampoos may be used on the day of a visit.

6. Subjects who have a concomitant diagnosis of congestive heart failure (CHF), including medically-controlled and or asymptomatic subjects.

7. Subjects who have a history of chronic or recurrent infectious disease, including: chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic cystitis), open skin wounds/ulceration that are draining or infected.

8. Subjects who have had or have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for this infection during the 2 months prior to visit 1.

9. Subjects who have or have had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to Visit 1.

10 Subjects who have or have had a Herpes zoster infection within 2 months prior to visit 1.

11. Subjects who are known to be infected with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).

12. Subjects who have a history of any clinically significant AEs (including allergic reactions) to murine or chimeric proteins or human/murine recombinant products.

13. Subjects who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.

14. Subjects who have a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.

15. Subjects who have current signs and symptoms or history of systemic lupus erythematosus.

16. Subjects who have a transplanted organ (with the exception of a corneal transplant >3 months prior to visit 1).

17. Subjects who have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.

18. Subjects who have any malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence).

19. Subjects who are unable or unwilling to und

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified