A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis. - DOSE

• Conditions: Moderate to severe plaque Psoriasis; MedDRA version: 11.0Level: LLTClassification code 10037153Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-000454-12-GR
• Lead Sponsor: Schering Plough Research Institute, a Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-06
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319
2. Subjects must be screened for this study within 8 weeks from their last infliximab infusion in P05319
3. Subjects must be randomized into this study, Study P05315, between Weeks 23 and 50 (inclusive) of Study P05319.
4. Subjects must have demonstrated a =25% and <75% improvement in PASI from Baseline of P05319 between Weeks 23 and 50 (inclusive) of the observational study P05319
5. Subjects must be =18 years of age
6. Subjects must be candidates for phototherapy or systemic treatment for psoriasis
7. Subjects must have met all the inclusion and not met any of the exclusion criteria for observational study P05319
8. Subjects must be willing and able to provide written informed consent and comply with the requirements of the study
9. Subjects must be willing and able to attend all study visits
10. Women of childbearing potential and all men must agree to use a medically accepted method of contraception prior to entering the study while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (eg, hysterectomy, tubal ligation for women, and vasectomy for men). Women of non-childbearing potential (menopausal) do not have to use any contraceptive methods (menopause is defined as the time when there has been no menstrual periods for 12 consecutive months and no other biological or physiological cause can be identified)
11. Women of childbearing potential and men who are not currently sexually active must agree to use a medically acceptable method of contraception should they become sexually active while participating in the study and receiving protocol-specified medication, and for 6 months after stopping the medication
12. Subjects are considered eligible according to the following tuberculosis (TB) criteria:
a. have no history of latent or active TB within 3 months 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 have active and latent TB ruled out prior to the first administration of study medication,
d. prior to or at the time of infliximab induction therapy during study P05319, EITHER:
i. have had negative diagnostic TB test results (interpreted as negative per local standards and laws), OR
ii. have had a newly identified positive TB test result during Baseline in which active or latent TB has been ruled out
13. Subjects’ Screening and Baseline clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) must be within the following parameters:
a. Hemoglobin =10 g/dL (=100 g/L)
b. White Blood Cells (WBC) =3.5 x 109 cells/L
c. Neutrophils =1.5 x 109 cells/L
d. Platelets =100 x 109 cells/L
e. Serum Creatinine <1.5 mg/dL (<133 ?mol/L)
f. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase, and Gamma-Glutamyltransferase (GGT) all =1.5 times upper limit of normal (ULN)
g. Total Bilirubin =1 times ULN
14. Subjects

Exclusion Criteria

1. Subjects for whom infliximab is contraindicated or not recommended
2. Subjects who currently have non-plaque forms of psoriasis
3. Subjects who currently have drug-induced psoriasis
4. Subjects who used any therapeutic agent (investigational or approved) targeted at reducing IL-12, IL-17, or IL-23 within the previous 6 months prior to Screening
5. Subjects who have used any investigational drug at any time within the previous 4 weeks prior to Screening
6. Subjects who have used immunosuppressants at any time within the previous 4 weeks prior to Screening
7. Subjects who have used any systemic medications (other than infliximab) that could affect psoriasis or PASI evaluations at any time within the previous 4 weeks prior to Screening
8. Subjects who have used a TNF-reducing agent other than infliximab at any time within the previous 4 weeks prior to Screening
9. Subjects with ongoing serious adverse events (SAEs) or AEs (as per physician discretion) that would prohibit further treatment with infliximab
10. Women who are breastfeeding, pregnant, or intend to become pregnant, and male study subjects with female partners who are breastfeeding, pregnant, or intend to become pregnant
11. Subjects who are staff personnel directly involved with this study
12. Subjects who are family members of the investigational study staff
13. Subjects with a known intolerance to methotrexate or contraindication to methotrexate
14. Subjects with a concomitant diagnosis of congestive heart failure (CHF), including medically controlled asymptomatic subjects
15. Subjects with a history of chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), and recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis) or open, draining, or infected skin wounds or ulcers
16. Subjects who have or have had an opportunistic infection (infection caused by an organism only in a host whose resistance is lowered by other diseases or by drugs, such as cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to Screening
17. Subjects who have or have had a herpes zoster infection within 2 months prior to Screening
18 Subjects who are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
19. Subjects who have a history of any clinically significant AEs or intolerance (including allergic reactions) to murine or chimeric proteins or human/murine recombinant products
20. Subjects who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
21. Subjects who have a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
22. Subjects who have current signs and symptoms or history of systemic lupus erythematosus
23. Subjects who have a transplanted organ (with the exception of a corneal transplant >3 months prior to Baseline)
24. 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
25. Subjects who have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that h

Study & Design

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