OsteoarthritisPhase 1NCT01072591
Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee
A Phase 1 study testing MEDI-578 in people with Osteoarthritis and Pain, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- MEDI-578
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Sep 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with painful osteoarthritis of the knee.
- The pain from the knee must exceed pain experienced from any other condition.
- Patients must be willing and able to discontinue all current analgesic treatment.
Who cannot join
- Any other form of arthritis than osteoarthritis.
- Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis.
- Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess Safety,Tolerability, Pharmacokinetics and Efficacy of MEDI-578, an Anti-NGF Monoclonal Antibody, After Single Ascending Doses in Male and Non-fertile Female Patients With Painful Osteoarthritis of the Knee
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.
- Conditions
- Osteoarthritis, Pain
- Being tested
- MEDI-578, Placebo for MEDI-578
- Keywords
- anti-NGF, OA, pain
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-578Drug
intravenous infusion, once
Placebo for MEDI-578Drug
Intravenous infusion, once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MEDI-578 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo for MEDI-578 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (adverse events, vital signs, ECG, safety lab)
Measured: Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.
Secondary outcomes (3)
To characterize the pharmacokinetics of MEDI-578 in plasma.
Measured: Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12.
To assess the immunogenicity of MEDI-578
Measured: Blood samples taken fortnightly from Day 1 until week 12.
To evaluate the analgesic efficacy of MEDI-578 during the night and day.
Measured: Patients will record their pain intensity every morning and evening during the 13 weeks study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Amended clinical development plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Rolf Karlsten, Study director, AstraZeneca RD Södertälje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072591
- Sponsor's protocol ID
- D2460C00001
- Status last verified
- Jan 2013
- First submitted
- 19 Feb 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess Safety,Tolerability, Pharmacokinetics and Efficacy of MEDI-578, an Anti-NGF Monoclonal Antibody, After Single Ascending Doses in Male and Non-fertile Female Patients With Painful Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01072591
- Acronym / sponsor ID
- D2460C00001
- Conditions
- Osteoarthritis, Pain
- Keywords
- anti-NGF, OA, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amended clinical development plan.
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Feb 2010 (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.
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-578 |
| 2 | Placebo comparator | Drug: Placebo for MEDI-578 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with painful osteoarthritis of the knee.
- The pain from the knee must exceed pain experienced from any other condition.
- Patients must be willing and able to discontinue all current analgesic treatment.
Key exclusion criteria (3 listed)
- Any other form of arthritis than osteoarthritis.
- Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis.
- Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.
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 |
|---|---|---|
| MEDI-578intravenous infusion, once | Drug | 1 |
| Placebo for MEDI-578Intravenous infusion, once | Drug | 2 |
Primary outcome
Safety variables (adverse events, vital signs, ECG, safety lab)
Time frame: Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.
3 secondary outcomes
To characterize the pharmacokinetics of MEDI-578 in plasma.
Time frame: Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12.
To assess the immunogenicity of MEDI-578
Time frame: Blood samples taken fortnightly from Day 1 until week 12.
To evaluate the analgesic efficacy of MEDI-578 during the night and day.
Time frame: Patients will record their pain intensity every morning and evening during the 13 weeks study period.
Results and safety
The study was stopped early (reason given: Amended clinical development plan.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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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.
Rolf Karlsten study director
AstraZeneca RD Södertälje
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 MEDI-578 in people with Osteoarthritis and Pain, run by AstraZeneca at 1 site in United Kingdom.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Jan 2013. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Amended clinical development plan.). Results are not available in the source record.
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?
Safety variables (adverse events, vital signs, ECG, safety lab) (time frame: Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2013.