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Study of Adalimumab in Subjects With Peripheral Spondyloarthritis

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peripheral Spondyloarthritis

Intervention: adalimumab (Biological); placebo (Biological); adalimumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
In-Ho Song, MD, Study Director, Affiliation: AbbVie

Summary

This study will study how well adalimumab works in the short and long term in subjects with peripheral spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

Clinical Details

Official title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Primary Outcome Measure

Adverse Events

Secondary outcome:

Physician's Global Assessment of Disease Activity (VAS)

Bath AS Disease Activity Index (BASDAI) Score & SF-36 v2 physical component

Health Assessment Questionnaire modified for the Spondyloarthropathies (HAQ-S)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult subjects with inadequate response to >/= 2 non-steroidal anti-inflammatories

(NSAIDs)

- Subjects must have current arthritis or enthesitis dactylitis PLUS: meeting

spondyloarthritis clinical criteria

- Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline

Visit must be Negative

- Ability to administer subcutaneous injections

- General good health otherwise

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 may put patients at risk for

participation

- Female subjects who are 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

Locations and Contacts

Site Reference ID/Investigator# 37361, Hobart 7001, Australia

Site Reference ID/Investigator# 26667, Malvern East 3145, Australia

Site Reference ID/Investigator# 26669, Maroochydore 4558, Australia

Site Reference ID/Investigator# 26671, Shenton Park 6008, Australia

Site Reference ID/Investigator# 26663, Genk 3600, Belgium

Site Reference ID/Investigator# 26672, Gent 9000, Belgium

Site Reference ID/Investigator# 26664, Gilly 6060, Belgium

Site Reference ID/Investigator# 26665, Montreal H2L 1S6, Canada

Site Reference ID/Investigator# 26674, St. John's A1C 5B8, Canada

Site Reference ID/Investigator# 26675, Winnipeg R3N OK6, Canada

Site Reference ID/Investigator# 29764, Brno 638 00, Czech Republic

Site Reference ID/Investigator# 37070, Pardubice 530 02, Czech Republic

Site Reference ID/Investigator# 29763, Prague 2 128 50, Czech Republic

Site Reference ID/Investigator# 29762, Uherske Hradiste 686 01, Czech Republic

Site Reference ID/Investigator# 27842, Amiens 80054, France

Site Reference ID/Investigator# 26678, Chambray-les-Tour 37170, France

Site Reference ID/Investigator# 26677, Paris Cedex 14 75679, France

Site Reference ID/Investigator# 26680, Berlin 12200, Germany

Site Reference ID/Investigator# 26679, Herne 44649, Germany

Site Reference ID/Investigator# 26681, Zerbst 39261, Germany

Site Reference ID/Investigator# 26682, Heraklion Crete 70013, Greece

Site Reference ID/Investigator# 26683, Thessaloniki 54636, Greece

Site Reference ID/Investigator# 26685, Debrecen H-4032, Hungary

Site Reference ID/Investigator# 26684, Szeged H-6725, Hungary

Site Reference ID/Investigator# 26688, Cork, Ireland

Site Reference ID/Investigator# 26687, Dublin 4, Ireland

Site Reference ID/Investigator# 27504, Barcelona 08036, Spain

Site Reference ID/Investigator# 26690, Cordoba 14004, Spain

Site Reference ID/Investigator# 37462, Lincoln, Nebraska 68515, United States

Site Reference ID/Investigator# 38693, Cleveland, Ohio 44109-1998, United States

Site Reference ID/Investigator# 26351, Duncansville, Pennsylvania 16635, United States

Site Reference ID/Investigator# 26366, Chattanooga, Tennessee 37404, United States

Site Reference ID/Investigator# 26353, Seattle, Washington 98104, United States

Site Reference ID/Investigator# 26756, Clarksburg, West Virginia 26301, United States

Additional Information

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Starting date: February 2010
Last updated: May 19, 2014

Page last updated: August 23, 2015

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