Study of Adalimumab in Subjects with Peripheral Spondyloarthritis

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Peripheral Spondyloarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014567-39-DE

Enrollment

154

Registered

2009-12-29

Start date

2010-02-19

Completion date

Unknown

Last updated

2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Spondyloarthritis MedDRA version: 16.1 Level: HLT Classification code 10052775 Term: Spondyloarthropathies System Organ Class: 100000004859

Interventions

Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult subjects with inadequate response to >= 2 non-steroidal anti-inflammatories (NSAIDS) 2. Subjects must have current arthritis, or enthesitis or dactylitis PLUS meeting spondyloarthitis clinical criteria 3. Negative purified protein derivative (PPD) test and Chest X-ray performed at Baseline must be negative 4. Ability to administer subcutaneous injections 5. General good health Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 156 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Prior anti-TNF use 2. Psoriasis or Psoriatic Arthritis 3. Fulfillment of modified New York criteria for Ankylosing Spondylitis 4. Recent infection requiring treatment 5. Significant medical events or conditions that may put patients at risk for participation.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to evaluate the efficacy and safety of adalimumab 40 mg given every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open-label safety and efficacy assessments in subjects with non-AS, non-PsA active peripheral spondyloarthritis who have had an inadequate response to = 2 Non-steroidal Anti-inflammatory drugs (NSAIDs), or are intolerant to or have a contraindication for NSAIDs.;Secondary Objective: N/A;Primary end point(s): >= 40% improvement from Baseline in Patient Global Assessment of Disease Activity and Patient Global Assessment of Pain and at least one of the following three criteria: 1) Swollen Joint count and Tender Joint Count 2) Enthesitis Count 3) Dactylitis Count;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: The objective of this study is to evaluate the efficacy and safety of adalimumab 40 mg given every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open-label safety and efficacy assessments in subjects with non-AS, non-PsA active peripheral spondyloarthritis who have had an inadequate response to = 2 Non-steroidal Anti-inflammatory drugs (NSAIDs), or are intolerant to or have a contraindication for NSAIDs.;Secondary Objective: N/A;Primary end point(s): >= 40% improvement from Baseline in Patient Global Assessment of Disease Activity and Patient Global Assessment of Pain and at least one of the following three criteria: 1) Swollen Joint count and Tender Joint Count 2) Enthesitis Count 3) Dactylitis Count;Timepoint(s) of evaluation of this end point: Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): Physician's Global Assessment of Disease Activity VAS BASDAI Score HAQ-S Sf-36 v2 physical component;Timepoint(s) of evaluation of this end point: Week 12	—

Countries

Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hungary, Ireland, Spain, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

euclinicaltrials@abbott.com+441628644475

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026