An Open-Label, Randomized Efficacy and Safety Study of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis

Phase 1

• Conditions: Moderate to severe psoriasis; MedDRA version: 7.1Level: PTClassification code 10037153

• Registration Number: EUCTR2005-000085-39-AT
• Lead Sponsor: Schering-Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-16
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

The subject must meet ALL of the criteria listed below for entry:
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-type psoriasis at least 6 months prior to Screening (subjects with concurrent psoriatic arthritis may be enrolled).
3. Subjects must have plaque-type psoriasis covering at least 10% of total BSA at Screening and Baseline.
4. Subjects must have a PASI score of 12 or greater at Screening and Baseline
(see Appendix 7).
5. Subjects must be candidates for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
6. Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
7. Subjects are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules. All subjects (except those who have received previous BCG vaccination) who have a negative intradermal skin test at Screening must be retested prior to Baseline with negative results in order to be eligible for participation in the study (see Section 7.6).
8. Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.
9. Subjects’ Screening and Baseline clinical laboratory tests (CBC, blood chemistry, and urinalysis) 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 (or <133 µmol/L), (f) Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase =1.5 x upper limit of normal, and (g) Total bilirubin =1 x upper limit of normal.
10. Subjects must be free of any clinically significant disease (other than psoriasis
or psoriatic arthritis) that would interfere with the study evaluations.
11. Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
12. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must continue using such measures until 6 months after receiving the last dose of study medication.
13. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening and a negative urine pregnancy test at Baseline.
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

The subject will be excluded from entry if ANY of the criteria listed below are met:
1. Subjects who have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
2. Subjects who have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
3. Female subjects who are pregnant, nursing, and both men and women who are planning pregnancy during the study period and the 6 months after study completion.
4. Subjects previously treated with infliximab.
5. Subjects previously treated with MTX.
6. Subjects who are currently taking or have taken the following drugs within the
specified time frame prior to Screening: (a) any therapeutic agent targeted at reducing TNF within 3 months, (b) any biologic within 3 months, (c) any live virus or bacterial vaccinations received within 3 months prior to Screening, (d) any systemic medications/treatments that could affect psoriasis or PASI evaluations within 4 weeks, (e) any systemic immunosuppressants within 4 weeks, (f) lithium within 4 weeks, and (g) any topical medications/treatments that could affect psoriasis or PASI
evaluation within 2 weeks.
7. Subjects who have a concomitant diagnosis of congestive heart failure (CHF),
including medically-controlled asymptomatic subjects.
8. Subjects who have a history of chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers.
9. Subjects who have had or have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months prior to Screening.
10. 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 Screening.
11. Subjects who have or have had a Herpes zoster infection within 2 months prior to Screening.
12. Subjects who are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C.
13. Subjects who have a history of any clinically significant AEs (including allergic
reactions) to murine or chimeric proteins or human/murine recombinant products.
14. Subjects who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
15. Subjects who have a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
16. Subjects who have current signs and symptoms or history of systemic lupus
erythematosus.
17. Subjects who have a transplanted organ (with the exception of a corneal transplant >3 months prior to Screening).
18. 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.
19. 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 has been treated with no evidence of recurrence).
20. Subjects who are unable or unwilling to undergo multiple v

Study & Design

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