A Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of two dose regimens of CC-10004 in subjects with active psoriatic arthritis
- Conditions
- Active psoriatic arthritis
- Registration Number
- EUCTR2006-004619-23-BE
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 204
• Must understand and voluntarily sign an informed consent form
• Must be male or female and aged = 18 years at time of consent
• Must have a diagnosis of psoriatic arthritis (Moll and Wright Criteria), including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
• Must have active psoriatic arthritis at the time of screening and baseline as
defined by:
3 or more swollen joints AND 3 or more tender joints
• Must have a negative rheumatoid factor (RF)
• If using methotrexate, must be on methotrexate for at least 168 days (24 weeks) and be on a stable dose for at least 56 days prior to screening and throughout the study
• If using oral corticosteroids, must be on a stable dose of prednisone = 10 mg/day or equivalent for at least 28 days prior to screening and throughout the study
• If using nonsteroidal anti-inflammatory drug (NSAID) therapy, must be on a stable dose for at least 14 days prior to screening and throughout the study
• Must meet the following laboratory criteria:
- Hemoglobin = 9 g/dL
- Hematocrit = 27%
- White blood cell (WBC) count = 3000 /µL (= 3.0 X 10e9/L) and
< 20,000/µL (< 20 X 10e9/L)
- Neutrophils = 1500 /µL (= 1.5 X 10e9/L)
- Platelets = 100,000 /µL (= 100 X 10e9/L)
- Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)
- Total bilirubin = 2.0 mg/dL
- Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) = 1.5x upper limit of normal (ULN)
• Must be able to adhere to the study visit schedule and other protocol requirements
• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner. A FCBP must agree to have pregnancy tests every 28 days while on study medication
• Males (including those who have had a vasectomy) must agree to use barrier
contraception (latex condoms) when engaging in reproductive sexual activity with
FCBP while on study medication and for at least 84 days after taking the last dose of
study medication
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
• History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Pregnant or lactating female
• History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.
• History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test [T-SPOT®.TB, QuantiFERON Gold®])
• Clinically significant abnormality on the chest x-ray (CXR) at screening
• Current erythrodermic, guttate, or pustular forms of psoriasis
• History of infected joint prosthesis within the past 5 years
• Systemic therapy for psoriasis and/or psoriatic arthritis (except for methotrexate, = 10 mg/day prednisone or equivalent, and NSAIDs) including, but not limited to, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids (including intra-articular), penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, and fumaric acid esters within 28 days of randomization and throughout the study
• Topical therapy for the treatment of psoriasis including, but not limited to, topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin within 14 days of randomization (Note: Topical background therapy for treatment of psoriasis is allowed, except within 24 hours of a study visit, as follows: mild or moderate potency corticosteroids for treatment of the palms, face, scalp, axillae, plantar surfaces, and groin in accordance with the manufacturer’s suggested usage. Nonmedicated emollients [e.g., Eucerin®] and tar shampoo are also allowed.)
• Phototherapy (ultraviolet light A [UVA], narrow-band ultraviolet light B [NB-UVB], psoralens and long-wave ultraviolet radiation [PUVA]) within 28 days prior to randomization
• Etanercept use within 56 days prior to randomization
• Adalimumab, efalizumab, or infliximab use within 84 days prior to randomization
• Alefacept use within 168 days (24 weeks) prior to randomization
• Use of intra-articular corticosteroids within 28 days prior to randomization
• Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
• Any clinically significant abnormality on 12-lead ECG at screening
• High-risk factor(s) for, or a history of, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection
• History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
• Evidence of skin conditions at the time of screening visit that would interfere with evaluations of the effect of study medication on psoriasis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method