a phase 2 study to investigate the safety, tolerability and efficacy of abt-122 in subjects with active psoriatic arthritis (psa) who have an inadequate response to methotrexate (mtx)

Conditions: Psoriatic Arthritis

Summary: this study is a phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of abt-122 in participants with active psa who are inadequately responding to mtx treatment.


Eligibility criteria:
inclusion criteria: * psa diagnosis of at least 3 months duration prior to the date of first screening with classification of psoriatic arthritis (caspar) confirmed diagnosis at screening. * have active psoriasis defined by at least 1 psoriasis lesion \>= 2 cm diameter in areas other than the axilla or groin. * have active arthritis defined by minimum disease activity criteria: 1. \>= 3 swollen joints (based on 66 joint counts) at screening 2. \>= 3 tender joints (based on 68 joint counts) at screening * on a stable dose of methotrexate (mtx) defined as: 1. oral or parenteral treatment \>= 3 months 2. on a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline 3. stable mtx dose of \>= 10 mg/week and \<= the upper limit of the applicable approved local label 4. can also be on stable doses of nonsteroidal anti-inflammatory drugs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate exclusion criteria: * up to 30% (approximately 66 subjects) with prior exposure to a tnf inhibitor may be enrolled if the tnf inhibitor was not discontinued due to lack of efficacy or safety concerns. subjects must be washed out for at least 5 half-lives of these drugs prior to the baseline visit. * subjects on prior adalimumab may not be enrolled in the study * prior exposure to other non-tnf inhibitor biological disease-modifying antirheumatic drugs (dmards) will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the baseline visit. * current treatment with traditional oral/intramuscular dmards, including conventional synthetic dmards (csdmards; except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to mtx). oral dmards must be washed out for at least 5 half-lives of a drug apart from mtx prior to the baseline visit. a. subject could have been exposed to prior janus kinase (jak) or phosphodiesterase type 4 (pde4) inhibitors so long as they have been off therapy for at least 5 half-lives. * stable prescribed dose of oral prednisone or prednisone equivalent \> 10 mg/day within the 30 days of the baseline visit. * intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the baseline visit. inhaled corticosteroids for stable medical conditions are allowed. * laboratory values of the following at the screening visit: 1. confirmed hemoglobin \< 9 g/dl for males and \< 8.5 g/dl for females 2. absolute neutrophil count (anc) \< 1500 mm\^3, (or \< 1200 cells/µl for subjects of african descent who are black) 3. aspartate aminotransferase or alanine aminotransferase \> 1.5 x the upper limit of normal (uln) or bilirubin \>= 3 mg/dl 4. serum creatinine \> 1.5 x the uln 5. platelets \< 100,000 cells/\[mm\^3\] (10\^9/l), 6. clinically significant abnormal screening laboratory results as evaluated by the investigator

Keywords: safety efficacy methotrexate