Study of Intra-articular DLX105 Applied to Patients With Severely Painful Osteoarthritis of the Knee

NCT00819572 | Completed Phase 1 DMC

• 1 other identifier: DLX105CRD02
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 10

Brief Summary

The purpose of this study is to determine whether an intra-articular injection of DLX105 to the knee joint of patients suffering from severly painful osteoarthritis is safe and reduces pain.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; TNF-alpha; DLX105; scFv antibody fragment; pain; fragment; antibody fragment

Outcome Measures

Primary Outcomes (2)

• Change from Baseline (Day 0) to Day 7 in a 100mm Visual Analogue Scale (VAS) to assess the intensity of knee pain.

  Day 7 after intra-articular injection

• Safety assessment during the study period. Safety endpoints will include the nature and incidence of AEs, physical examination findings, changes in vital signs, and laboratory test results.

  8 weeks / 12 weeks

Secondary Outcomes (1)

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC™) scoring

  Day 7 after intra-articular injection

Study Arms (3)

1

EXPERIMENTAL

DLX105 low dose

Biological: DLX105, a single-chain (scFv) antibody fragment against TNF-alpha

2

EXPERIMENTAL

DLX105 high dose

Biological: DLX105, a single-chain (scFv) antibody fragment against TNF-alpha

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DLX105, a single-chain (scFv) antibody fragment against TNF-alpha BIOLOGICAL

Comparison of two different doses of intra-articular DLX105

1; 2

Placebo DRUG

3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index \< 30.
• Patients with diagnosed OA of the knee (unilateral or bilateral) according to the American College of Rheumatology (ACR) Criteria for classification of idiopathic OA (clinical and radiological criteria) of the knee at Screening (for ACR criteria, see Appendix 16.1).
• Radiographic evidence of tibiofemoral OA within the last 6 months before Screening, consisting of Grade II or Grade III changes, according to Kellgren-Lawrence grading system.
• Presence of pain in the index knee (in case of bilateral OA, "index knee" is the more painful knee) defined by a level of ≥ 60 mm on a 100 mm (linear) VAS at Screening.
• Paracetamol and NSAIDs (apart from acetyl salicylic acid ≤ 100 mg/day) must be withdrawn at least 24 hours prior to Screening .
• Doses of "chondroprotective" agents containing glucosamine and/or chondroitin sulphate must be stable for at least 3 months prior to Screening.
• Doses of any non-prescription medication claiming effects on signs or symptoms of OA must be stable for at least 3 months prior to Screening.
• Use of non-pharmacological treatment modalities must be stable for at least 3 months prior to Screening.
• Negative QuantiFERON-TB Gold test.

You may not qualify if:

• Radiographic evidence of tibiofemoral OA within the last 6 months before Screening, consisting of Grade IV, according to Kellgren-Lawrence grading system.
• Instability of the index knee joint of \> 10° as assessed by goniometer at Screening.
• Arthroscopic or open surgery to the index knee joint within 6 months prior to Screening.
• Post-traumatic or any other secondary OA of the knee.
• Isolated OA of the patello-femoral joint.
• Co-morbidity that would confound measurement of knee pain
• Evidence of any inflammatory arthritis.
• History of Reiter's Syndrome, RA, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis, or any other inflammatory disease (immune mediated inflammatory disease) that may affect the knee.
• Local or systemic contraindication for an i.a. injection at Screening or Baseline.
• Any i.a. injection (corticosteroids, hyaluronic acid, etc.) within the 3 months prior to Screening.
• History of high risk exposure to Mycobacterium tuberculosis.
• Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
• Uncontrolled diabetes or cardiovascular disease (New York Heart Association criteria III + IV), including uncontrolled hypertension (\> 160/100 mmHg).
• Active infectious episodes, or history of recurrent or chronic systemic infections.
• Malignancy within 5 years prior to Screening, except for surgically-cured non melanoma skin cancer or cervical carcinoma in situ.

Sponsors & Collaborators

• ESBATech AG: lead

Study Sites (10)

Prof. Dr. med. Georg Schett

Erlangen, 91054, Germany

Location

Dr. René Martz

Hamburg, 22143, Germany

Location

Dr. Sven Ostermeier

Hanover, 30625, Germany

Location

Prof. Dr. Manfred Hartard

Munich, 80809, Germany

Location

Rheumaklinik Kantonsspital Aarau

Aarau, 5000, Switzerland

Location

Rheumatologische Universitäts-Poliklinik, Felix-Platter Spital Basel

Basel, 4055, Switzerland

Location

Service de rhumatologie, Centre Hospitalier Universitaire, Lausanne

Lausanne, 1005, Switzerland

Location

Kantonsspital St.Gallen, Rheumatologie

Sankt Gallen, 9007, Switzerland

Location

Zentrum für Rheuma und Knochenerkrankungen

Zurich, 8038, Switzerland

Location

Universitätsspital Zürich, Rheumaklinik

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Georg Schett, MD

  University Hospital of Erlangen, Germany

  STUDY CHAIR

• Prof. Hansjörg Häuselmann, MD

  Rheumazentrum, Zurich Switzerland (Country Coordinator)

  PRINCIPAL INVESTIGATOR

• PD.Dr. Diego Kyburz, MD

  University Hospital Zurich, Switzerland (Country Coordinator)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

DE (4); CH (6)