A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee

NCT00456157 | Completed Phase 1

• 1 other identifier: 06-OA-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to investigate the safety and tolerability of OP-1 when it is injected into the knee joint of patients who have osteoarthritis on the knee.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Osteophytes; Knee; Intra-articular; OP-1

Outcome Measures

Primary Outcomes (1)

• Determine safety and tolerability as well as dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of intraarticular OP-1

Secondary Outcomes (8)

• Determine the proportion of patients with 20%, 50%, and 70% improvement in the Western Ontario and McMaster (WOMAC) pain, and function subscales at 4, 8, 12, and 24 weeks.

• Determine the change from baseline to 4, 8, 12, and 24 weeks in the pain, other symptoms, function in daily living, function in sports and recreation and knee related quality of life subscales of the Knee and Osteoarthritis Outcome Score (KOOS) survey.

• Determine the change from baseline to 4, 8, 12, and 24 weeks in the patient's global assessment and disease status and physician's global assessment and disease status using the 100-mm visual-analogue scale (VAS).

• Quality of life measured by the Short Form (SF)-36 at baseline and 4, 8,12 and 24 weeks

• Amount of rescue medications required at 4, 8, 12 and 24 weeks

Interventions

Intra-articular Injection of OP-1 to affected knee DRUG

Eligibility Criteria

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

You may qualify if:

• Ambulatory subjects with OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. Symptoms must include knee joint pain, and may include crepitus, swelling and/or effusion of the knee. In subjects with bilateral knee OA, the more symptomatic knee is the index knee. Subjects may be taking NSAIDs, analgesics and/or undergoing physical therapy.
• Age \> 40 years
• Radiographic evidence on posteroanterior (PA) and lateral standing, flexed x-rays of at least one osteophyte.
• Subjects must be willing to abstain from other intraarticular treatments of the knee or any surgery for 12 weeks on study.
• Ability to comply with the study and give informed consent.
• Subjects must be willing to abstain from NSAIDs or analgesic medications (except for acetaminophen) for 48 hours prior to assessments, at screening, day 1 and week 4, 8, 12, and 24 visits.

You may not qualify if:

• Concurrent medical or arthritic conditions which could interfere with evaluation of the index knee joint including fibromyalgia.
• Subject has received arthroscopic or open surgery to the index joint within 6 months of study start
• The presence of surgical hardware or other foreign body in the index joint
• Corticosteroid, hyaluronic acid or other intraarticular injection within 3 months of study start
• Use of chondroitin and/or glucosamine within 4 weeks prior to study start
• History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
• Clinical signs and symptoms of active knee infection or crystal disease
• Clinically significant cardiac disease, consult study Medical Monitor
• Have an increased predisposition for the development of infections
• History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
• More significant pain from the back or the hip than the knee
• Skin breakdown at the knee where the injection would take place
• Planned knee replacement during the study period
• For subjects undergoing MRI, the presence of contraindications to having an MRI at the specific imaging facility.
• For subjects undergoing MRI, an estimated Glomerular Filtration Rate (eGFR) of \<45 mL/min calculated using the Cockcroft-Gault estimate for eGFR as follows:

Sponsors & Collaborators

• Stryker Biotech: lead

Study Sites (3)

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118-2526, United States

Location

University of orth Carolina School of Medicine

Chapel Hill, North Carolina, 27599-7280, United States

Location

Related Publications (1)

• Hunter DJ, Pike MC, Jonas BL, Kissin E, Krop J, McAlindon T. Phase 1 safety and tolerability study of BMP-7 in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2010 Oct 10;11:232. doi: 10.1186/1471-2474-11-232.

  PMID: 20932341 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Osteophyte

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Exostoses; Hyperostosis; Bone Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: March 1, 2007
• Study Completion: November 1, 2008
• Last Updated: June 17, 2010

Record last verified: 2010-06

Locations

US (3)