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Publication Detail
Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double-blinded, randomized, dose-escalating trial
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Choy EH, Hazleman B, Smith M, Moss K, Lisi L, Scott DG, Patel J, Sopwith M, Isenberg DA
  • Publication date:
    10/2002
  • Pagination:
    1133, 1137
  • Journal:
    RHEUMATOLOGY (OXFORD)
  • Volume:
    41
  • Issue:
    10
  • Keywords:
    administration & dosage, adolescent, adult, adverse effects, age, Aged, ALPHA, analysis, antibodies, Antibodies, Monoclonal, Antibody, Arthritis, Arthritis, Rheumatoid, Blood, clinical, Clinical trial, CLINICAL-TRIAL, CONTROLLED TRIAL, disease, DMARD, dose, DOUBLE BLIND, DOUBLE-BLIND, Double-Blind Method, DURATION, effects, EFFICACY, experimental, FACTOR ALPHA, FACTOR-ALPHA, Female, FOLLOW, FOLLOW UP, Follow-up, FRAGMENT, FRAGMENTS, glycol, HALF LIFE, Half-Life, IM, IMMUNOGLOBULIN, Immunoglobulin Fragments, immunology, IMPROVEMENT, INFUSION, INTRAVENOUS, LA, Methods, MG, Middle Age, N, necrosis, NECROSIS-FACTOR-ALPHA, novel, Observation, Patient, patients, phase, PHASE II, PHASE-II, PLACEBO, plasma, Polyethylene Glycols, population, Prednisolone, product, PRODUCTS, randomized, RANDOMIZED CONTROLLED TRIAL, Result, Rheumatoid arthritis, RHEUMATOID-ARTHRITIS, SINGLE, small, THERAPIES, therapy, TNF ALPHA, TNF-ALPHA, treatment, Treatment Outcome, TRIAL, Tumor, tumor necrosis, Tumor Necrosis Factor, TUMOR-NECROSIS-FACTOR, Tumour, tumour necrosis, washout
  • Notes:
    UI - 22251277 DA - 20021004 IS - 1462-0324 LA - eng PT - Clinical Trial PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial RN - 0 (Antibodies, Monoclonal) RN - 0 (CDP870) RN - 0 (Immunoglobulin Fragments) RN - 0 (Polyethylene Glycols) RN - 0 (Tumor Necrosis Factor) SB - AIM SB - IM
Abstract
OBJECTIVE: Biological products that neutralize tumour necrosis factor alpha (TNF-alpha) are beneficial in rheumatoid arthritis (RA). We studied the effects of CDP870, a novel anti-TNF-alpha antibody fragment modified to obtain a prolonged plasma half-life ( approximately 14 days). METHODS: Thirty-six patients were randomized in a double-blind, ascending-dose group study to a single intravenous infusion of placebo (n = 12) or 1, 5 or 20 mg/kg CDP870 (each n = 8). The patients were predominantly female (30/36), had a mean age of 56 yr and a mean duration of RA of 13 years. They had received a mean of five DMARDs or experimental therapies (with 1 month washout before the study started) and had active disease. Continuation of NSAIDs and up to 7.5 mg prednisolone daily was allowed. Following the blinded dosing period, 32 patients received a single open-label infusion of either 5 or 20 mg/kg CDP870. RESULTS: In the blinded dosing period, 6/12 placebo patients withdrew from the study (for deteriorating RA < or =4 weeks after dosing). Two of 24 CDP870-treated patients withdrew, both in the 1 mg/kg group (for deteriorating RA or lost to follow up >4 weeks after dosing). The proportion of patients with ACR20 improvement for the per-protocol population with the last observation carried forward was 16.7, 50, 87.5 and 62.5% after 0, 1, 5 and 20 mg/kg CDP870 respectively (combined treatment effect, P = 0.012, primary analysis) at 4 weeks and 16.7, 25, 75 and 75% (P = 0.032) at 8 weeks. The proportion of patients with ACR50 improvement for the per-protocol population with the last observation carried forward was 0, 12.5, 12.5 and 50% after 0, 1, 5 and 20 mg/kg CDP870 respectively (combined treatment effect, P = 0.079) at 4 weeks and 0, 12.5, 12.5 and 50% (P = 0.079) at 8 weeks. Following the open-label dose of CDP870, similar beneficial effects were achieved. CONCLUSION: CDP870 is effective, was very well tolerated in this small study, and has an extended duration of action following one or more intravenous doses
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