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Sponsored by: |
ESBATech AG |
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Information provided by: | ESBATech AG |
ClinicalTrials.gov Identifier: | NCT00819572 |
The purpose of this study is to determine whether an intra-articular injection of ESBA105 to the knee joint of patients suffering from severly painful osteoarthritis is safe and reduces pain.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis |
Biological: ESBA105, a single-chain (scFv) antibody against TNF-alpha Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomised, Placebo-Controlled Phase I/IIa Study to Investigate the Safety, Tolerability and Efficacy on Pain of Intra-Articular ESBA105 Applied to Patients With Severely Painful Osteoarthritis of the Knee |
Estimated Enrollment: | 126 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
ESBA105 low dose
|
Biological: ESBA105, a single-chain (scFv) antibody against TNF-alpha
Comparison of two different doses of intra-articular ESBA105
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2: Experimental
ESBA105 high dose
|
Biological: ESBA105, a single-chain (scFv) antibody against TNF-alpha
Comparison of two different doses of intra-articular ESBA105
|
3: Placebo Comparator | Drug: Placebo |
Treatment options for patients suffering from osteoarthritis remain limited. TNF-alpha has been identified as a major pro-inflammatory component inducing and perpetuating peripheral hyperalgesia and cartilage degeneration in various preclinical studies. ESBA105 is an antibody fragment of comparably low molecular weight, associated with an exceptional local biodistribution pattern upon intra-articular injection. In addition, due to its short systemic half life as compared to conventional monoclonal antibodies, systemic exposure to ESBA105 upon intra-articular administration is low. This study is designed to determine the safety and local tolerability profile of single intra-articular injections of ESBA105 as well as to define ESBA105's effect size and effect duration in reducing pain of patients suffering from severely painful osteoarthritis of the knee. The study will be conducted in two sequential parts. In a first part, 4 different doses of ESBA105 will be compared in a sequential, escalating scheme against placebo treatment in a total of 24 patients. In the second part of the study, two doses of ESBA105 chosen based on safety data from the first part will be compared to placebo treatment in a total of 102 patients.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional criteria for the sub-population of patients undergoing MRI:
Switzerland | |
Rheumatologische Universitäts-Poliklinik, Felix-Platter Spital Basel | Recruiting |
Basel, Switzerland, 4055 | |
Contact: Ulrich Walker, MD bettina.bannert@fps-basel.ch | |
Principal Investigator: Ulrich Walker, MD | |
Kantonsspital St.Gallen, Rheumatologie | Recruiting |
St.Gallen, Switzerland, 9007 | |
Contact: Johannes von Kempis, MD Ruediger.Mueller@kssg.ch | |
Principal Investigator: Johannes von Kempis, MD | |
Zentrum für Rheuma und Knochenerkrankungen | Recruiting |
Zurich, Switzerland, 8038 | |
Contact: Hansjörg Häuselmann, MD sekretariathjh@rheumazentrum.ch | |
Switzerland, Aargau | |
Rheumaklinik Kantonsspital Aarau | Recruiting |
Aarau, Aargau, Switzerland, 5000 | |
Contact: Paul Hasler, MD Alexander.Iseli@ksa.ch | |
Principal Investigator: Paul Hasler, MD | |
Switzerland, Vaud | |
Service de rhumatologie, Centre Hospitalier Universitaire, Lausanne | Recruiting |
Lausanne, Vaud, Switzerland, 1005 | |
Contact: Alexander KI So, MD Daniele.Lorin-Belhoucine@chuv.ch | |
Principal Investigator: Alexander KI So, MD | |
Switzerland, Zurich | |
Universitätsspital Zürich, Rheumaklinik | Recruiting |
Zürich, Zurich, Switzerland, 8091 | |
Contact: Diego Kyburz, MD sandra.blumhardt@usz.ch |
Study Chair: | Georg Schett, MD | University Hospital of Erlangen, Germany |
Principal Investigator: | Hansjörg Häuselmann, MD | Rheumazentrum, Zurich Switzerland |
Principal Investigator: | Diego Kyburz, MD | University Hospital Zurich, Switzerland |
Responsible Party: | ESBATech AG ( Peter Lichtlen, Medical Director ) |
Study ID Numbers: | ESBA105CRD02 |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819572 |
Health Authority: | Switzerland: Swissmedic; Switzerland: Ethikkommission |
Osteoarthritis TNF-alpha ESBA105 scFv antibody pain |
Osteoarthritis, Knee Antibodies Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |