A Phase 1 interventional study of ABT-122 and Placebo in Rheumatoid Arthritis, sponsored by AbbVie. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 19 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
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Exclusion Criteria:
Randomized 6 drug/2 placebo by group
Biological: ABT-122 · Biological: Placebo
Randomized 6 drug/2 placebo by group
Biological: ABT-122 · Biological: Placebo
Randomized 6 drug/2 placebo by group
Biological: ABT-122 · Biological: Placebo
Injection
Placebo Injection
Number of participants with Adverse Events
Collect all adverse events at each visit
Time frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in physical exam including vital signs
Blood pressure, pulse and body temperature
Time frame: From date of first dose of ABT-122 until 42 days after last dose of ABT-122
Change in clinical lab test results
Hematology, Chemistry, and Urinalysis
Time frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in Electrocardiogram (ECG) results
ECGs done in triplicate
Time frame: From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
Determination of pharmacokinetic (PK) parameters
Cmax, Tmax, AUC, elimination rate constant and half-life
Time frame: Prior to first dose up to 42 days after the last dose of ABT-122
Measurement of anti-drug anti-bodies (ADA) of ABT-122
Measurement of ADA
Time frame: Prior to each dose and up until 42 days after the last dose of ABT-122
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ABT-122