Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

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 objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to \>= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.

Related Clinical Trials

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

Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

NCT00085644

Ankylosing Spondylitis

COMPLETED PHASE3

Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

NCT00646386

Arthritis Psoriatic

COMPLETED PHASE2

Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

NCT00646178

Arthritis Psoriatic

COMPLETED PHASE3

Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

NCT00649545

Rheumatoid Arthritis

APPROVED_FOR_MARKETING

A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

NCT00448383

Rheumatoid Arthritis

COMPLETED PHASE3

Detailed Description

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

Conditions

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

Peripheral Spondyloarthritis

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Double-blind (DB) Adalimumab

Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.

Group Type EXPERIMENTAL

Adalimumab

Intervention Type BIOLOGICAL

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

Double-blind Placebo

Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.

Double-blind Adalimumab / Open-label Adalimumab

Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.

Group Type EXPERIMENTAL

Adalimumab

Intervention Type BIOLOGICAL

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

Double-blind Placebo / Open-label Adalimumab

Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.

Group Type PLACEBO_COMPARATOR

Adalimumab

Intervention Type BIOLOGICAL

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

Placebo

Intervention Type BIOLOGICAL

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.

Interventions

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

Adalimumab

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

Intervention Type BIOLOGICAL

Placebo

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-D2E7 Humira

Eligibility Criteria

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

Inclusion Criteria

* Adult participants who had inadequate response to \>= 2 non-steroidal anti-inflammatories (NSAIDs)
* Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
* Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
* Ability to administer subcutaneous injections
* General good health

Exclusion Criteria

* Prior anti-tumor necrosis factor (TNF) therapy
* Psoriasis or Psoriatic Arthritis
* Fulfillment of modified New York criteria for Ankylosing Spondylitis
* Recent infection requiring treatment
* Significant medical events or conditions that had put patients at risk for participation
* Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study
* History of cancer, except successfully treated skin cancer
* Recent history of drug or alcohol abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No