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Who can enter the trial
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Inclusion Criteria:
- Active Rheumatoid Arthritis (RA) for 6 months or more.
- Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
- Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg,
inclusive.
- Males, unless surgically sterile, must use 2 effective methods of birth control from
Day 1 through follow-up.
Exclusion Criteria:
- History or presence of any clinically significant disease or disorder which has not
been stable over the previous 3 months.
- History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
- Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica,
giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
- Current, chronic pain disorders including fibromyalgia and chronic regional pain
syndromes or chronic fatigue syndromes.
- Intramuscular steroid injection or intraarticular steroid injection within 1 month of
enrollment.
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Who cannot enter the trial
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Inclusion Criteria:
- Active Rheumatoid Arthritis (RA) for 6 months or more.
- Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
- Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg,
inclusive.
- Males, unless surgically sterile, must use 2 effective methods of birth control from
Day 1 through follow-up.
Exclusion Criteria:
- History or presence of any clinically significant disease or disorder which has not
been stable over the previous 3 months.
- History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
- Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica,
giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
- Current, chronic pain disorders including fibromyalgia and chronic regional pain
syndromes or chronic fatigue syndromes.
- Intramuscular steroid injection or intraarticular steroid injection within 1 month of
enrollment.
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Secondary Aim
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Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(?z), terminal half-life (t1/2 ?z).; From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.; No; Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-t)] and from zero to infinity (AUC).; From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.; No; Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of concentration at Weeks 6 and 12 [AUC(0-6w) and AUC(0 12w)].; From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.; No; Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).; From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.; No; Description of pharmacodynamics in terms of total interleukin 6 (IL-6) and free IL-6 (exploratory) in plasma and high sensitive C-reactive protein (hs-CRP) pre and post MEDI5117 or placebo administration and their corresponding change from baseline.; From Baseline day -1 to week 64; No; Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood.; From Baseline day -1 to week 64; No
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