Active psoriatic arthritis
Conditions
Interventions
Product Name: CC-10004
Product Code: CC-10004
Pharmaceutical Form: Capsule, hard
Current Sponsor code: CC-10004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the 84-day clinical efficacy of 2 dose regimens of CC-10004 (20 mg per os [PO] twice per day [BID, total daily dose of 40 mg] or 40 mg PO once per day [QD], subsequent to a 7-day dose titration), compared with placebo, for the treatment of active psoriatic arthritis;Secondary Objective: •evaluate safety,tolerability,effect on quality of life,PD effect and estimate systemic exposure of 20mg BID & 40mg QD of CC-10004 v placebo • examine PK/PD relationship between 20mg BID & 40mg QD of CC-10004 and PD activity/clinical outcomes Exploratory: •evaluate clinical efficacy of 20mg PO BID & 40mg PO QD of CC-10004 v placebo Extension Phase (Secondary): •evaluate safety and tolerability of 20mg PO BID & 40mg PO QD of CC 10004 in ASA subjects treated with CC-10004 for 168 days, and in 84-day Extension Phase in ASA subjects formerly treated with placebo •evaluate 168-day clinical efficacy of 2 dose regimens of CC-10004 (20mg PO BID or 40mg PO QD) for ASA •compare severity of disease at Day 169 & 85 in subjects randomized to placebo •determine effect of 20mg PO BID & 40mg PO QD of CC-10004 on quality of life in ASA subjects treated with CC-10004 for 168 days, and in 84-day Extension Phase for ASA subjects formerly treated with placebo;Primary end point(s): Treatment Phase: Proportion of subjects in each treatment group who achieve the American College of Rheumatology criteria for 20% improvement (ACR 20) at Day 85 (Final Treatment Phase Visit)/Early Termination from Treatment Phase Visit compared with baseline. | — |
Countries
Belgium, Germany, Netherlands, United Kingdom
Outcome results
None listed