A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee.
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01668511
First received: August 1, 2012
Last updated: March 15, 2013
Last verified: March 2013
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Purpose
To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Biological: ABT-981 Biological: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled Study in Patients With Osteoarthritis of the Knee to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of ABT-981 |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Number of participants with Adverse Events [ Time Frame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 ] [ Designated as safety issue: Yes ]Collect all adverse events at each visit
- Physical Exam including vital signs [ Time Frame: From date of first dose of ABT-981 until 70 days after last dose of ABT-981 ] [ Designated as safety issue: Yes ]Blood pressure, heart rate and body temperature
- Clinical Lab Testing [ Time Frame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 ] [ Designated as safety issue: Yes ]Hematology, Chemistry, and Urinalysis
- Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Prior to dose and 8 hours post dose on each day of dosing ] [ Designated as safety issue: Yes ]ECGs done in triplicate
- Maximum observed serum concentration (Cmax) of ABT-981 [ Time Frame: Prior to first dose up to 70 days after the last dose of ABT-981 ] [ Designated as safety issue: No ]Cmax
- Time to Cmax (Tmax) of ABT-981 [ Time Frame: Prior to first dose up to 70 days after the last dose of ABT-981 ] [ Designated as safety issue: No ]Time to Cmax
- The area under the time curve (AUC) of ABT-981 [ Time Frame: Prior to first dose up until 70 days after the last dose of ABT-981 ] [ Designated as safety issue: No ]AUC
- The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 [ Time Frame: Prior to the last dose up to 70 days after the last dose of ABT-981 ] [ Designated as safety issue: No ]The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
Secondary Outcome Measures:
- Measurement of anti-drug anti-bodies (ADA) of ABT-981 [ Time Frame: Prior to each dose and up until 70 days after the last dose of ABT-981 ] [ Designated as safety issue: Yes ]Measurement of ADA
| Estimated Enrollment: | 36 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Randomized 7 drug/2 placebo by group
|
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection
|
|
Experimental: Group 2
Randomized 7 drug/2 placebo by group
|
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection
|
|
Experimental: Group 3
Randomized 7 drug/2 placebo by group
|
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection
|
|
Experimental: Group 4
Randomized 7 drug/2 placebo by group
|
Biological: ABT-981
Injection
Biological: Placebo
Placebo Injection
|
Detailed Description:
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Thirty-six patients with osteoarthritis of the knee will be selected to participate. Patients will be randomized to receive either ABT-981 or placebo. ABT-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. Subjects will be administered subcutaneous injections of ABT-981 for up to 8 weeks.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult male or female, 40 to 70 years of age, inclusive.
- History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms
- Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3
- Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale
- Other than Osteoarthritis (OA) of the study joint, patient should be in general good health
Exclusion Criteria:
- Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA
- History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent
- Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint
- Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.
- Any uncontrolled medical illness including unstable treatment or therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668511
Contacts
| Contact: Renee Heuser, BS | 847-938-5887 | renee.heuser@abbvie.com |
| Contact: Michelle Kirchoff, BA | 847-937-9165 | michelle.kirchoff@abbvie.com |
Locations
| United States, Florida | |
| Site Reference ID/Investigator# 78613 | Recruiting |
| Miami, Florida, United States, 33136 | |
| Principal Investigator: Site Reference ID/Investigator# 78613 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Susanne X. Wang, MD | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01668511 History of Changes |
| Other Study ID Numbers: | M12-756 |
| Study First Received: | August 1, 2012 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Immunogenicity Safety Pharmacokinetics, Tolerability Osteoarthritis |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013