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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

NCT02433340

Rheumatoid Arthritis

COMPLETED PHASE2

A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

NCT01741493

Rheumatoid Arthritis

COMPLETED PHASE1

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

NCT00254293

Rheumatoid Arthritis

COMPLETED PHASE1/PHASE2

A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy

NCT01960855

Rheumatoid Arthritis

COMPLETED PHASE2

Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients

NCT01001832

Rheumatoid Arthritis

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Randomized 6 drug/2 placebo by group

Group Type EXPERIMENTAL

ABT-122

Intervention Type BIOLOGICAL

Injection

Placebo

Intervention Type BIOLOGICAL

Placebo Injection

Group 2

Randomized 6 drug/2 placebo by group

Group Type EXPERIMENTAL

ABT-122

Intervention Type BIOLOGICAL

Injection

Placebo

Intervention Type BIOLOGICAL

Placebo Injection

Group 3

Randomized 6 drug/2 placebo by group

Group Type EXPERIMENTAL

ABT-122

Intervention Type BIOLOGICAL

Injection

Placebo

Intervention Type BIOLOGICAL

Placebo Injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-122

Injection

Intervention Type BIOLOGICAL

Placebo

Placebo Injection

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No