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Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria

Phase 3
18 Years
Open (Enrolling)
Peripheral Spondylarthritis

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Trial Information

Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria

Inclusion Criteria:

A subject will be eligible for study participation if all of the following criteria are

- Subject is ≥ 18 years of age

- Subjects must meet the new Assessment of SpondyloArthritis (ASAS) criteria for
peripheral spondyloarthritis:

o Subjects must have current arthritis (asymmetric or predominantly in the lower
limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac
joints and/or chest wall) or current dactylitis PLUS:

- At least 1 of the following Peripheral Spondyloarthritis (SpA) features:

- Anterior uveitis confirmed by an ophthalmologist(past or present)

- Crohn's disease or ulcerative colitis diagnosed by a gastroenterologist (past or

- Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or
cervicitis 1month before arthritis)

- Psoriasis diagnosed by a dermatologist (past or present)

- Human Leukocyte Antigen (HLA) B27 positivity

- Sacroiliitis by imaging defined as bilateral grade 2-4 or unilateral grade 3-4
sacroiliitis on plain radiographs, according to the modified New York criteria
or active sacroiliitis on Magnetic Resonance Imaging (MRI) according to the ASAS
consensus definition (ref of addendum)

- Subjects must have had onset of peripheral SpA symptoms ≤ 3 months prior to the
screening visit

- Subjects must have active disease at screening and baseline, defined by Patient
Global Assessment of Disease Activity Visual Analog Scale (VAS) ≥ 40mm and Patient
Global Assessment of Pain VAS ≥ 40mm at screening and baseline visits.

- In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be
the predominant symptoms at study entry based on the Investigator's clinical

- Subject has a negative Purified Protein Derivative (PPD) test (or equivalent) and
Chest radiography (posteroanterior (PA) and lateral view) at screening. If the
subject has a positive PPD test (or equivalent), has had a past ulcerative reaction
of PPD placement and/or a Chest radiography consistent with prior TB exposure, the
subject must initiate, or have documented completions of a course of
anti-Tuberculosis therapy.

- Patients must undergo screening for Hepatitis B Virus (HBV) (this includes testing
for HBsAg (Hepatitis B surface Antigen), anti-HBs (Hepatitis B surface antibody) and
anti-HBc total (Hepatitis B core antibody total).

- Women of childbearing potential or men capable of fathering children must be using
adequate birth control measures during the study and for 6 months after receiving the
last administration of study agent. Female patients of childbearing potential must
test negative for pregnancy.

- If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy) or is of childbearing potential and is practicing an
approved method of birth control throughout the study and for 6 months after last
dose of study drug.

Examples of approved methods of birth control include the following:

- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)

- Oral, parenteral or intravaginal contraceptives for 90 days prior to study drug

- A vasectomized partner

- Subject is judged to be in good health as determined by the principal
investigator based upon the results of medical history, laboratory profile,
physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG)
performed during screening.

- Subjects must be able and willing to provide written informed consent and comply
with the requirements of this study protocol.

- Subjects must be able and willing to self-administer sc injections or have a
qualified person available to administer subcutaneous injections.

Exclusion Criteria:

- Medical history of inflammatory arthritis of a different etiology other than
peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus
erythematosus, gout, or any arthritis with onset prior to age 16 years such as
Juvenile idiopathic arthritis (JIA)).

- Prior exposure to any biologic therapy with a potential therapeutic impact on SpA,
including anti-TNF therapy.

- Treatment with any investigational drug of chemical or biological nature within a
minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to the
Baseline Visit.

- Infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days
prior to the Baseline visit or oral anti-infectives within 14 days prior to the
Baseline Visit.

- Have a known hypersensitivity to human immunoglobulin proteins or other components of

- History of Central Nervous System (CNS) demyelinating disease or neurologic symptoms
suggestive of CNS demyelinating disease.

- History of listeriosis, histoplasmosis, chronic of active Hepatitis B infection,
Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency
syndrome, chronic recurring infections or active TB.

- Have a history of, or concurrent, chronic heart failure, including medically
controlled, asymptomatic Congestive Heart Failure (CHF).

- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia)
other than a successfully treated non-metastatic cutaneous squamous cell or basal
cell carcinoma or localized carcinoma in situ of the cervix.

- Have received, or are expected to receive, any live virus or bacterial vaccination
within 3 months prior to the first administration of study agent, during the trial,
or within 6 months after the last administration of study agent.

- Positive pregnancy test at screening or baseline.

- Female subjects who are breast-feeding or considering becoming pregnant during the

- History of clinically significant drug or alcohol abuse in the last 12 months.

- Clinically significant abnormal screening laboratory results as evaluated by the

- Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP)
antibody at screening if the titers are crossing 3 times the upper limit of the

- Subject is considered by the investigator, for any reason, to be an unsuitable
candidate for the study.

- Subject with diagnosis and current symptoms of fibromyalgia.

Type of Study:


Study Design:

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

Outcome Measure:

Clinical remission

Outcome Description:

The primary endpoint of the study is the induction of clinical remission (complete resolution of synovitis/dactylitis/enthesitis which was present at baseline) and prevention of newly developing peripheral and/or axial spondylarthritis signs). The primary analysis will be a comparison at 24 weeks of the percentage of patients in clinical remission in the group treated with the Tumor Necrosis Factor (TNF)-blocking agent versus placebo.

Outcome Time Frame:

At 24 weeks

Safety Issue:


Principal Investigator

Filip Vandenbosch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ghent University Hospital


Belgium: Ethics Committee

Study ID:




Start Date:

March 2012

Completion Date:

November 2013

Related Keywords:

  • Peripheral Spondylarthritis
  • Peripheral spondylarthritis according to ASAS- criteria
  • Spondylarthritis