A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853033
• Other study ID #: M14-048
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2013
• Last updated: November 16, 2017
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• ABT-122
Injection
• Placebo
Placebo Injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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