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

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2009-010643-14-BE
• Date of registration: 13/07/2009
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Axial Spondyloarthritis
• Scientific title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Axial Spondyloarthritis
• Date of first enrolment: 08/10/2009
• Target sample size: 194
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010643-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, France, Germany, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
Adults subjects (18 years old and older) with intolerance or insufficient response to at least 1 NSAID;
Chronic back pain with onset prior to age 45;
MRI indicating active sacroiliitis or HLA-B27 positive blood test in addition to meeting spondyloarthritis clinical criteria

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 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
Prior anti-TNF use;
Psoriasis or Psoriatic Arthritis;
Fulfillment of modified New York criteria for Ankylosing Spondylitis;
Recent infection requiring treatment;
History of cancer (except skin cancer).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Active axial spondyloarthritis
MedDRA version: 14.1 Level: PT Classification code 10051265 Term: Spondyloarthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Other descriptive name: ABT-Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: N/A

Primary end point(s): The primary efficacy variable is the proportion of subjects who have achieved ASAS40 response at the Week 12 Visit.

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 active axial spondyloarthritis not fulfilling the modified New York criteria for AS who have had an inadequate response to, or intolerance to one or more NSAIDs or have a contraindication for NSAIDs.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Secondary end point(s): Variables that will be analyzed at Week 12:
ASAS20;
BASDAI 50;
SF-36v2 physical component;
ASAs partial remission;
ASAS5/6 response;
HAQ-S;
hs CRP value;
Mean change in SPARCC MRI score for sacroiliac joints;
Mean change in SPARCC MRI score for the spine.

Timepoint(s) of evaluation of this end point: Week 12

Secondary ID(s)

M10-791

2009-010643-14-FR

Source(s) of Monetary Support

AbbVie Inc.