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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-13

Study Completion Date

2019-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 3 months of symptom duration) of patients with predominant peripheral spondyloarthritis (SpA), classified according to the new Assessment of SpondyloArthritis (ASAS)-criteria. The hypothesis would be that treatment with a TNF-blocker at this early ("immature") stage of the disease would result in a significant higher number of patients in clinical remission compared to placebo, and that - comparable to the early Rheumatoid Arthritis (RA) patients in the BeSt-study - long-term treatment would not be necessary to maintain this remission in a number of patients.

In this placebo-controlled, double blind, randomized study (with open-label phase, starting at week 24) sixty patients fulfilling the Assessment of SpondyloArthritis (ASAS) criteria of peripheral spondylarthritis will be enrolled. Patients will be randomized in a 2:1 ratio (2 golimumab :1 placebo). During the placebo-controlled phase, 50mg golimumab, or placebo will be administrated subcutaneously (SC) every 4 weeks through week 20. Subjects will be treated with open-label Golimumab 50 mg SC injections at weeks 24, 28, 32, 36, 40, 44, and 48. If patients are in 'clinical remission' (clinical remission is defined by the absence of arthritis, enthesitis and dactylitis clinically at two major consecutive visits. Visits are planned at week 12, week 24, week 36 and week 48) then the treatment will be stopped. In case of clinical relapse, patients will be treated with open-label golimumab 50 mg SC. Patients in sustained clinical remission will be observed to assess the possibility of maintaining drug-free remission. The study duration will be 48 weeks.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation

NCT03270501

Axial Spondyloarthritis

COMPLETED PHASE3

A Study of Golimumab in Participants With Active Ankylosing Spondylitis

NCT02186873

Ankylosing Spondylitis

COMPLETED PHASE3

A Study of Golimumab in Participants With Active Psoriatic Arthritis

NCT02181673

Arthritis, Psoriatic

COMPLETED PHASE3

NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis

NCT02758782

Ankylosing Spondylitis

COMPLETED PHASE4

Initial Treatment With Golimumab in Early PsA

NCT01871649

Psoriatic Arthritis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Spondylarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The prefilled syringe with placebo will be administrated subcutaneously every 4 weeks during a study period of 24 weeks.

Golimumab 50mg (Simponi ®)

Group Type EXPERIMENTAL

Golimumab

Intervention Type DRUG

The prefilled syringe with golimumab 50mg (Simponi ®) will be administrated subcutaneously every 4 weeks during a study period of 48 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

The prefilled syringe with placebo will be administrated subcutaneously every 4 weeks during a study period of 24 weeks.

Intervention Type DRUG

Golimumab

The prefilled syringe with golimumab 50mg (Simponi ®) will be administrated subcutaneously every 4 weeks during a study period of 48 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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 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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No