Rheumatoid Arthritis Clinical Trial
Official title:
A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
Verified date | June 2014 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
Status | Completed |
Enrollment | 19 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Rheumatoid Arthritis (RA) > 3 months. - On methotrexate (MTX) therapy => 3 months and on a stable dose for at least 4 weeks. - Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer. - Body Mass Index (BMI) is 19 to 38, inclusive. - Other than RA, subjects should be in good general health. Exclusion Criteria: - Evidence of anti-ABT-122 antibody on a serum sample taken at Screening. - History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product. - History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days. - History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB. - Subject has any medical condition or illness other than RA that is not well controlled with treatment. |
Country | Name | City | State |
---|---|---|---|
United States | Site Reference ID/Investigator# 100780 | Dallas | Texas |
United States | Site Reference ID/Investigator# 118964 | Duncansville | Pennsylvania |
United States | Site Reference ID/Investigator# 108655 | Lenexa | Kansas |
United States | Site Reference ID/Investigator# 107115 | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States,
Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-a- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacoki — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with Adverse Events | Collect all adverse events at each visit | From date of first dose of ABT-122 until 42 days after the last dose of ABT-122 | |
Primary | Change in physical exam including vital signs | Blood pressure, pulse and body temperature | From date of first dose of ABT-122 until 42 days after last dose of ABT-122 | |
Primary | Change in clinical lab test results | Hematology, Chemistry, and Urinalysis | From date of first dose of ABT-122 until 42 days after the last dose of ABT-122 | |
Primary | Change in Electrocardiogram (ECG) results | ECGs done in triplicate | From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug | |
Primary | Determination of pharmacokinetic (PK) parameters | Cmax, Tmax, AUC, elimination rate constant and half-life | Prior to first dose up to 42 days after the last dose of ABT-122 | |
Secondary | Measurement of anti-drug anti-bodies (ADA) of ABT-122 | Measurement of ADA | Prior to each dose and up until 42 days after the last dose of ABT-122 |
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