OsteoarthritisPhase 1NCT01668511
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee
A Phase 1 study testing ABT-981 in people with Osteoarthritis, run by AbbVie (prior sponsor, Abbott) at 1 site in United States.
Trial summary
To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ABT-981
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 78613
Miami, Florida, 33136
About this study
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
To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- ABT-981, Placebo
- Keywords
- Immunogenicity, Safety, Tolerability, Osteoarthritis, Pharmacokinetics
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-981Biological
Injection
PlaceboBiological
Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Randomized 7 drug/2 placebo by group Receives: Biological: ABT-981; Biological: Placebo |
| Group 2 | Experimental | Randomized 7 drug/2 placebo by group Receives: Biological: ABT-981; Biological: Placebo |
| Group 3 | Experimental | Randomized 7 drug/2 placebo by group Receives: Biological: ABT-981; Biological: Placebo |
| Group 4 | Experimental | Randomized 7 drug/2 placebo by group Receives: Biological: ABT-981; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
Collect all adverse events at each visit
Measured: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Physical Exam including vital signs
Blood pressure, heart rate and body temperature
Measured: From date of first dose of ABT-981 until 70 days after last dose of ABT-981
Clinical Lab Testing
Hematology, Chemistry, and Urinalysis
Measured: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981
Change from Baseline in Electrocardiogram (ECG)
ECGs done in triplicate
Measured: Prior to dose and 8 hours post dose on each day of dosing
Maximum observed serum concentration (Cmax) of ABT-981
Cmax
Measured: Prior to first dose up to 70 days after the last dose of ABT-981
Time to Cmax (Tmax) of ABT-981
Time to Cmax
Measured: Prior to first dose up to 70 days after the last dose of ABT-981
The area under the time curve (AUC) of ABT-981
AUC
Measured: Prior to first dose up until 70 days after the last dose of ABT-981
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
Measured: Prior to the last dose up to 70 days after the last dose of ABT-981
Secondary outcomes (1)
Measurement of anti-drug anti-bodies (ADA) of ABT-981
Measurement of ADA
Measured: Prior to each dose and up until 70 days after the last dose of ABT-981
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susanne X. Wang, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668511
- Sponsor's protocol ID
- M12-756
- Status last verified
- Nov 2013
- First submitted
- 1 Aug 2012
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang SX, Abramson SB, Attur M, Karsdal MA, Preston RA, Lozada CJ, Kosloski MP, Hong F, Jiang P, Saltarelli MJ, Hendrickson BA, Medema JK. Safety, tolerability, and pharmacodynamics of an anti-interleukin-1alpha/beta dual variable domain immunoglobulin in patients with osteoarthritis of the knee: a randomized phase 1 study. Osteoarthritis Cartilage. 2017 Dec;25(12):1952-1961. doi: 10.1016/j.joca.2017.09.007. Epub 2017 Sep 28.
PubMed 28964890
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01668511
- Acronym / sponsor ID
- M12-756
- Conditions
- Osteoarthritis
- Keywords
- Immunogenicity, Safety, Tolerability, Osteoarthritis, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: ABT-981, Biological: PlaceboRandomized 7 drug/2 placebo by group |
| Group 2 | Experimental | Biological: ABT-981, Biological: PlaceboRandomized 7 drug/2 placebo by group |
| Group 3 | Experimental | Biological: ABT-981, Biological: PlaceboRandomized 7 drug/2 placebo by group |
| Group 4 | Experimental | Biological: ABT-981, Biological: PlaceboRandomized 7 drug/2 placebo by group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-981Injection | Biological | Group 1, Group 2, Group 3, Group 4 |
| PlaceboPlacebo Injection | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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
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
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
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
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
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
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
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
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Results publication: PubMed 28964890Wang SX, Abramson SB, Attur M, Karsdal MA, Preston RA, Lozada CJ, Kosloski MP, Hong F, Jiang P, Saltarelli MJ, Hendrickson BA, Medema JK. Safety, tolerability, and pharmacodynamics of an anti-interleukin-1alpha/beta dual variable domain immunoglobulin in patients with osteoarthritis of the knee: a randomized phase 1 study. Osteoarthritis Cartilage. 2017 Dec;25(12):1952-1961. doi: 10.1016/j.joca.2017.09.007. Epub 2017 Sep 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne X. Wang, MD study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-981 in people with Osteoarthritis, run by AbbVie (prior sponsor, Abbott) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.