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 1

• Conditions: Early stage peripheral Spondyloarthritis (SpA); MedDRA version: 18.1 Level: LLT Classification code 10056449 Term: Spondyloarthrosis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-003678-97-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-07
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Subject is = 18 years of age
- Subjects must meet the new ASAS classification criteria for peripheral spondyloarthritis
- 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 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 PPD test (or equivalent) and Chest radiography (PA and lateral view) at screening. If the subject has a positive PPD test (or equivalent), has had a past ulcerative reaction following 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-TB therapy.
- Patients must undergo screening for HBV (this includes testing for HBsAg (surface antigen), anti-HBs (surface antibody) and anti-HBc total (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.
- Female subjects must agree to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of study agent. Male subjects must agree to not donate sperm while in the study and for 6 months after last dose of study agent
- 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 sc injections.

CRESPA-Extension’
Subjects will be allowed to participate in the ‘CRESPA-Extension’ part of the study if they are considered good candidates for chronic anti-TNF treatment and fulfill one of the following 2 scenarios:
- Patients participating in ‘CRESPA’ that experienced sustained clinical remission of arthritis/enthesitis/dactylitis on 2 consecutive major study visits, and in whom withdrawal of golimumab treatment provoked a flare of peripheral SpA during the follow-up.
- Patients participating in ‘CRESPA’ that experienced a major improvement at the week 48 ‘end-of-study’ visit, without however reaching clinical remission. Major improvemen

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 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 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, CHF, including medically controlled, asymptomatic 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified