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Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bone morphogenetic protein 7

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
>40 years
Radiographic evidence of at least one osteophyte in either knee at screening

Exclusion Criteria

Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
Received arthroscopic or open surgery to the index knee within 6 months of screening
History of joint replacement surgery (index knee).
Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
Long acting hyaluronic acid injection of the index knee within 6 months of screening
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
Female subject with reproductive capability.

Sites / Locations

Florida Medical Research Institute
Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

0.03 mg/ml BMP-7 or placebo via intraarticular knee injection

0.1 mg/ml BMP-7 or placebo via intraarticular knee injection

0.3 mg/ml BMP-7 or placebo via intraarticular knee injection

Outcomes

Primary Outcome Measures

Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)

Secondary Outcome Measures

WOMAC pain and function

Patient and physician global VAS

Quality of life measurement (SF-36) and pain medication use

Full Information

NCT ID

NCT01133613

First Posted

May 27, 2010

Last Updated

January 30, 2012

Sponsor

Stryker Biotech

1. Study Identification

Unique Protocol Identification Number

NCT01133613

Brief Title

Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stryker Biotech

4. Oversight

5. Study Description

Brief Summary

The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

0.03 mg/ml BMP-7 or placebo via intraarticular knee injection

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

0.1 mg/ml BMP-7 or placebo via intraarticular knee injection

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

0.3 mg/ml BMP-7 or placebo via intraarticular knee injection

Intervention Type

Drug

Intervention Name(s)

Bone morphogenetic protein 7

Intervention Description

Single intraarticular injection of BMP-7 or placebo on Day 1

Primary Outcome Measure Information:

Title

Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)

Time Frame

Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

Secondary Outcome Measure Information:

Title

WOMAC pain and function

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24

Title

Patient and physician global VAS

Time Frame

Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

Title

Quality of life measurement (SF-36) and pain medication use

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. >40 years Radiographic evidence of at least one osteophyte in either knee at screening Exclusion Criteria Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia) Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily. Received arthroscopic or open surgery to the index knee within 6 months of screening History of joint replacement surgery (index knee). Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening Long acting hyaluronic acid injection of the index knee within 6 months of screening History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia. History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ. Female subject with reproductive capability.

Facility Information:

Facility Name

Florida Medical Research Institute

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

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