{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T11:28:31Z","timestamp":1784546911491,"version":"3.55.0"},"reference-count":22,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2014,5,23]],"date-time":"2014-05-23T00:00:00Z","timestamp":1400803200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Protalex Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2014,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>PRTX\u2010100 is a highly\u2010purified preparation of staphylococcal protein A (SpA), with immunologic activity in vitro and in animal models of immune\u2010mediated inflammation. Following single\u2010dose healthy volunteer studies of safety and pharmacokinetics (PK), a multicenter, double\u2010blind, placebo\u2010controlled, sequential dose\u2010escalation, repeated\u2010dose phase I trial was conducted in patients with active rheumatoid arthritis (RA) on methotrexate therapy. Patients were randomized to receive either weekly intravenous PRTX\u2010100 (0.15, 0.45, 0.90, or 1.50\u2009\u00b5g\/kg) or placebo for 4 weeks. Safety and disease activity were assessed over 16 weeks. Pharmacokinetic profiles were obtained after the first and fourth doses. The most common treatment\u2010related adverse events were nausea, muscle spasms, dizziness, flushing, fatigue, RA flare, and headache. No serious adverse events were considered related to PRTX\u2010100, and none occurred in the highest dose group. Geometric mean values for plasma C<jats:sub>max<\/jats:sub> (ng\/mL) were 4.1, 15.7, 26.5, and 51.2 for doses of 0.15, 0.45, 0.90, and 1.5\u2009\u00b5g\/kg, respectively. Anti\u2010drug antibodies (ADAs) developed in most PRTX\u2010100 patients, but incidence and titer were not dose\u2010dependent. At the two highest doses, data suggest PRTX\u2010100 may have an effect on RA disease activity, even in patients with ADAs.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.116","type":"journal-article","created":{"date-parts":[[2014,3,11]],"date-time":"2014-03-11T11:48:26Z","timestamp":1394538506000},"page":"477-486","source":"Crossref","is-referenced-by-count":11,"title":["PRTX\u2010100 and methotrexate in patients with active rheumatoid arthritis: A Phase Ib randomized, double\u2010blind, placebo\u2010controlled, dose\u2010escalation study"],"prefix":"10.1002","volume":"3","author":[{"given":"Edward","family":"Bernton","sequence":"first","affiliation":[{"name":"Protalex, Inc. Summit NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Gannon","sequence":"additional","affiliation":[{"name":"Protalex, Inc. Summit NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Kramer","sequence":"additional","affiliation":[{"name":"Kramer Consulting LLC Rockville MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduard","family":"Kranz","sequence":"additional","affiliation":[{"name":"Parexel Clinical Pharmacology Bloemfontein South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,5,23]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.97.10.5399"},{"key":"e_1_2_8_3_1","doi-asserted-by":"crossref","first-page":"1877","DOI":"10.4049\/jimmunol.147.6.1877","article-title":"Human IgA and IgG F(ab\u2032)2 that bind to staphylococcal protein A belong to the VHIII subgroup","volume":"147","author":"Sasso EH","year":"1991","journal-title":"J Immunol."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.30629"},{"key":"e_1_2_8_5_1","doi-asserted-by":"crossref","first-page":"2237","DOI":"10.1182\/blood.V79.9.2237.2237","article-title":"Experience with protein A\u2010immunoadsorption in treatment\u2010resistant adult immune thrombocytopenic purpura","volume":"79","author":"Synder HW","year":"1992","journal-title":"Blood."},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(199910)42:10<2153::AID-ANR16>3.0.CO;2-W"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/0955-3886(94)00064-Q"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.176.4.2262"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2004.04333.x"},{"key":"e_1_2_8_10_1","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1128\/iai.55.3.803-809.1987","article-title":"Mechanism of activation of human basophils by staphylococcus aureus Cowan","volume":"55","author":"Marone G","year":"1987","journal-title":"Infect Immunol."},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.1985.tb02062.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780310302"},{"key":"e_1_2_8_13_1","first-page":"1204","article-title":"PK\/PD relationships in a sequential, escalating, single\u2010dose study of PRTX\u2010100, a highly purified staphylococcal protein A","volume":"47","author":"Goldwater R","year":"2007","journal-title":"J Clin Pharmacol."},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.119"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380602"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keh297"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.084459"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380107"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1155\/2011\/146398"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1875-9114.1998.tb03934.x"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1086\/374553"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.99.17.2302"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2003.1380"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.116","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.116","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T21:07:47Z","timestamp":1696626467000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.116"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,5,23]]},"references-count":22,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2014,11]]}},"alternative-id":["10.1002\/cpdd.116"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.116","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,5,23]]}}}