Raptiva in Palm and Sole Psoriasis

Launched by MERCK KGAA, DARMSTADT, GERMANY · Sep 4, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria:
• • 1. Subjects must have moderate to severe chronic (disease history of at least 6 months from diagnosis) plaque psoriasis involving the palms and/or soles (PPPASI =/\>5) at screening, and must be candidates for phototherapy and systemic therapies.
• • 2. Subjects must be outpatients.
• • 3. Subjects must have stable disease at study entry (i.e. no exacerbation of psoriasis during the screening period).
• • 4. Subjects must not have received any systemic psoriasis medication at least 14 days prior to the first administration of investigational medicinal product.
• • 5. Subjects must not have received any topical psoriasis medication at least 14 days prior to the first administration of investigational medicinal product (emollients are allowed, as well as low potency steroids to the face and/or groin).
• • 6. Subjects must be at least 18 years old at the time that the informed consent is obtained.
• • 7. Female subjects of childbearing potential must use an adequate method of contraception to prevent pregnancy and must agree to continue to practice adequate contraception for the duration of their participation in the study (up to the last safety follow up visit). For male subjects, it is mandatory to practice birth control during participation in the trial, as there are no data on the effect of Raptiva® on spermatogenesis. For the purposes of this trial, women of childbearing potential are defined as "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive." Adequate contraception is defined as two barrier methods, or one barrier method with spermicide, or an intrauterine device or use of the oral female contraceptive.
• • 8. Subjects must have discontinued all biological agents at least 3 months prior to the first study treatment injection.
• • 9. Subjects must have discontinued any investigational drug or treatment at least 3 months prior to study Day 0 and/or as per washout requirements from previous protocol.
• • 10. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
• • 11. Subjects must have provided their written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent
• Exclusion Criteria:
• To be eligible for inclusion in this trial, the subjects must not meet any of the following criteria:
• • 1. Hypersensitivity to Raptiva®/matching placebo or to any of their excipients.
• • 2. Current use of any prohibited therapy (systemic or topical treatments for psoriasis, such as retinoids; immunosuppressive drugs such as methotrexate, cyclosporine A, azathioprine, or mycophenolate mofetil, or any other experimental drug).
• • 3. Previous or current exposure to Raptiva®.
• • 4. History of or ongoing alcohol or drug abuse.
• • 5. History of or ongoing opportunistic infection or other serious infection. This includes any infections from the following list: Pneumocystis carinii, cytomegalovirus organ infections, Candida albicans (excluding simple localised muco-cutaneous infections), mycobacterium infections, Cryptococcus neoformans, Toxoplasma gondii, herpes simplex (excluding localised oral or genital muco-cutaneous infection), herpes zoster (excluding simple shingle eruption), cryptosporidium, Isospora belli, coccidioidomycosis, aspergillosis, histoplasmosis, and nocardiosis. This also includes diagnoses requiring more than 2 weeks of therapy, such as endocarditis and osteomyelitis treated in the past 6 months. In addition, if the subject is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression of or prophylaxis for any diagnosis, the subject will be excluded.
• • 6. Seropositivity for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Subjects will undergo testing during screening; any subjects who are found to be seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded, and proper diagnosis and further therapy will be recommended.
• • 7. Presence of active tuberculosis.
• • 8. Presence or history of malignancy including lymphoproliferative disorders.
• • 9. Pregnancy or breast-feeding.
• • 10. History of hepatic cirrhosis, regardless of cause or severity.
• • 11. History or presence of thrombocytopenia, haemolytic anaemia, clinically significant anaemia, a white blood cell count \<4,000 cells/μL or \>14,000 cells/μL, a haematocrit (HCT) \<30%, a haemoglobin (Hgb) level \<11 g/dL, or a platelet count \<150,000 cells/μL.
• • 12. Hepatic enzyme levels =/\>3 times the upper limit of normal or serum creatinine level =/\>2 times the upper limit of normal.
• • 13. Vaccination with a live or live-attenuated vaccine within the 14 days prior to the first dose of investigational medicinal product.
• • 14. Any medical condition that, in the judgment of the Investigator, would jeopardise the subject's safety following exposure to investigational medicinal product (Raptiva® or placebo equivalent) or would significantly interfere with the subject's ability to comply with the provisions of this protocol.
• • 15. Other specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
• • 16. Immunodeficiencies.
• • 17. Signs and symptoms suggestive of transmissible spongiform encephalopathy or family history of such.