17 research outputs found

    Study design.

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    <p>In the first stage, 8 patients were randomized 3∶1 to receive 90 µg TNF-K or placebo, in the second, 16 patients were randomized 3∶1 to receive 180 µg TNF-K or placebo, and in the third, 17 patients were randomized 3∶1 to receive 360 µg TNF-K or placebo. In each stage, patients were also randomized 1∶1 to receive 2 doses (day 0, 28) or 3 doses (day 0, 7, 28) (arrows). For stages 1 and 2, after 3 patients had been enrolled and no safety issues had been reported for at least 7 days, enrolment in the subsequent stage started in parallel. One patient randomized to receive 3 doses of 360 µg TNF-K withdrew consent prior to treatment. The principal analysis portion of the study continued up to day 84, and the follow-up portion continued up to month 12.</p

    Humoral immune response to TNF.

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    <p>Patients were treated with 2 doses (days 0 and 28) or 3 doses (days 0, 7, and 28) of placebo or 90, 180, or 360 µg TNF-K. Anti-TNF antibody titers were determined by enzyme-linked immunosorbent assay. (A) GMTs. (B) Percent of patients in each treatment group with detectable anti-TNF antibodies (titer ≥200) up to month 3 (at study day 38, 56, or 84), at month 6, at month 12, or at any time up to month 12 (i.e., antibody responders).</p

    Difference from baseline for clinical assessments in anti-TNF antibody responders and non-responders.

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    <p>Post-hoc analyses: Mean changes in clinical assessments from baseline are shown at months 3, 6, and 12 for antibody responders (detectable anti-TNF antibodies at any time; gray bars) and for non-responders (white bars). (A) DAS28-CRP. (B) CRP. (C) Tender joints count. (D) Swollen joints count. (E) Patient’s global activity score. (F) Physician’s global activity score. (G) Patient assessment of pain. (H) Change in HAQ disability/function score. Error bars indicate standard error of the mean. P-values were determined by Wilcoxon rank-sum test. NS, not significant (p≥0.05). In responders, n = 19 at month 3, 16 at months 6 and 12 except at month 3 for Physician GAS n = 18 and for CRP n = 20. In non-responders, n = 17 at month 3 and 15 at months 6 and 12 except at month 6 n = 14 for CRP and DAS 28 score.</p

    T cell response to TNF.

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    <p>Peripheral blood mononuclear cells were collected on days 0 and 56 and treated in vitro with medium (control) or with 10 µg/mL TNF-K, TNF, or KLH. Lymphoproliferation was assessed after 72 h by <sup>3</sup>H-thymidine incorporation. Shown is the stimulation index (fold-increase in lymphoproliferation vs. control) for cells from patients treated with placebo (n = 6) or TNF-K (n = 10).</p
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