Status:
COMPLETED
Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Janssen Biologics B.V.
Conditions:
Peripheral Spondylarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this Investigator Initiated study, the investigators want to explore the potential of an induction therapy with Tumor Necrosis Factor (TNF)-blocking agents in a very early disease stage (less than ...
Eligibility Criteria
Inclusion
- A subject will be eligible for study participation if all of the following criteria are met:
- 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 present)
- 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 judgment.
- 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 administration
- 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
- 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 golimumab.
- 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 study.
- History of clinically significant drug or alcohol abuse in the last 12 months.
- Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
- 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 normal
- 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.
Key Trial Info
Start Date :
March 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01426815
Start Date
March 13 2012
End Date
March 18 2019
Last Update
May 29 2019
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000