A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain
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Purpose
The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: RN624 (PF-04383119) Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety and Efficacy of RN624 in Adults With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee |
- Walking knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
- Overall knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
- Incidence of adverse events and serious adverse events [ Time Frame: Day 112 ] [ Designated as safety issue: Yes ]
- WOMAC [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
| Enrollment: | 450 |
| Study Start Date: | March 2006 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
monoclonal antibody
|
Drug: RN624 (PF-04383119)
10 mcg/kg
|
| Experimental: 2 |
Drug: RN624 (PF-04383119)
25 mcg/kg
|
| Experimental: 3 |
Drug: RN624 (PF-04383119)
50 mcg/kg
|
| Experimental: 4 |
Drug: RN624 (PF-04383119)
100 mcg/kg
|
| Experimental: 5 |
Drug: RN624 (PF-04383119)
200 mcg/kg
|
| Placebo Comparator: placebo | Drug: placebo |
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).
Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
Exclusion Criteria:
History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders
Contacts and Locations
Show 48 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00394563 History of Changes |
| Other Study ID Numbers: | A4091008, RN624-CL006 |
| Study First Received: | October 30, 2006 |
| Last Updated: | October 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
osteoarthritis monoclonal antibody |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013