A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Refractory Heel Enthesitis in Spondylarthropathy

Phase 1

• Conditions: Refractory heel enthesitis in spondylarthropathy.

• Registration Number: EUCTR2006-002749-35-FR
• Lead Sponsor: Wyeth Pharmaceuticals France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-28
• Study Completion: 2008-07-21
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosis of spondylarthropathy (SpA), as defined by the Amor’s criteria.
2. Heel enthesitis (pain located to the posterior and/or inferior part).
• MRI positive: presence of bone edema in the calcaneum adjacent to the insertion site of either Achileus tendon or fascia plantaris.
• Refractory to standard anti-rheumatic treatment (NSAIDS, for a duration > 3 months at the maximum tolerated dose, appropriate local treatment).
• The patient global assessment of the disease activity (measured by a 100 mm VAS) must be > 40 in the last 48 hours.
3. Between 18 and 70 years of age.
4. Negative serum pregnancy test taken at screening in all women except those surgically sterile or at least 1 year post-menopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who uses contraceptives or whose sexual partners are either sterile or use contraceptives.
5. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or post menopausal to use of a reliable method of birth control for the duration of the study.
6. Ability to reconstitute and self-inject drug or have a designee who can do so.
7. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific screening procedures are performed.
8. Ability to store injectable test article at 2°C-8°C.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of > 1 local steroid injection within two weeks of screening.
2. Previous receipt of etanercept or other TNFa inhibitors.
3. Use of disease modifying drugs other than hydroxychloroquine, sulphasalazine and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
4. Use of bisphosphonates within 3 months of baseline evaluation
5. Receipt of multiple NSAIDs at baseline.
6. Dose of NSAIDs changed within 2 weeks of baseline evaluation
7. Dose of prednisone > 10mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
8. Abnormality in chemistry or haematologic profiles : white blood cell count = 3.5 x 109/L; haemoglobin = 85 g/L or 5.3 mmol/L; haematocrit = 27%; platelet count = 125 x 109/L; serum creatinine = 175 µmol/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2 times the laboratory’s upper limit of normal.
9. Significant concurrent medical events :
• Uncompensated congestive heart failure.
• Diagnosis of multiple sclerosis or other central demyelinating diseases.
• Presence or history of confirmed blood dyscrasias.
• Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma).
• Serious infection (infection association with hospitalization and/or intravenous antibiotics) within 1 month of test article administration or active infection at baseline.
• Any condition that, in the physician’s judgment, might cause this study to be detrimental to the subject.
• History of HIV+ or TB+ test.
10. Known contraindication or hypersensitivity to etanercept or its excipients.
11. Pregnant or breast-feeding women.
12. History of poor compliance.
13. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
14. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements or give informed consent.
15. Receipt of any investigational drug or biological agent within 3 months of screening visit.
16. Employment by the investigator or reporting directly or indirectly to the investigator.

Study & Design

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