OsteoarthritisPhase 2NCT00110942
Treatment for Patients With Osteoarthritis (OA)
A Phase 2 study testing Systemic AMG 108 in people with Osteoarthritis, run by Amgen.
Trial summary
The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg subcutaneously [SC] every 4 weeks) in subjects with OA. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Systemic AMG 108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Nov 2005
- Phase
- Phase 2
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria
- Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
- If currently taking any over the counter nutritional supplements, must be on stable doses for greater than 2 months prior to screening
- If utilizing physical therapy, biomechanical devices or orthotic support, must have been using treatment or device for greater than or equal to 2 months prior to screening
- If currently or previously taking any non-prescribed supplement (e.g., glucosamine or chondroitin sulphate, shark cartilage, diacerein, soya extract, etc.) must be on stable doses for at least 2 months prior to screening
- If currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), must be on stable doses for at least 2 months prior to screening
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- Able to discontinue NSAIDs at least 5 half-lives (approximately 3 days) prior to Day 1
- Radiographic evidence of tibio-femoral compartment knee OA within 12 months of screening
- Signed written informed consent
Who cannot join
- Malignancy within the previous 5 years, except for basal cell or in situ cancer
- Significant hematologic disease - Active infection or history of recurrent or chronic infections
- Known diagnosis of HIV, hepatitis B, or hepatitis C infection
- Uncontrolled diabetes or cardiovascular disease and hypertension
- Inflammatory arthropathy including secondary OA
- Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement are not exclusions)
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- End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4)
- OA of the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 10^9/L and/or platelet count less than 100 x 10^9/L observed within 1 month preceding screening
- Prior intra-articular (IA) injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with SC anakinra
- Concurrent or recent (less than or equal to 1 month) use of experimental therapy
- Prior IA corticosteroid injection within 1 month of study
- Prior viscosupplement therapy within 3 months of study
- Contraindication(s) to IA injections
- Subjects who are pregnant or breast-feeding, or plan to become pregnant during the study
- Subject is not using adequate contraception
- Known allergy to E coli-derived products
- Unable to understand informed consent
- Concerns regarding subject's compliance with the protocol procedures
- Subject will not be available for follow-up assessment
- Active substance abuse
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Systemic AMG 108 in Subjects With Osteoarthritis (OA)
The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg subcutaneously [SC] every 4 weeks) in subjects with OA.
- Conditions
- Osteoarthritis
- Being tested
- Systemic AMG 108, Placebo
- Keywords
- Intra-articular, Osteoarthritis, OA, anakinra, Amgen
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic AMG 108Drug
300 mg SC AMG 108 Q4W for 3 doses
PlaceboOther
SC placebo injection Q4W for 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Minor sub-study AMG 108 | Active comparator | N = 15 Receives: Drug: Systemic AMG 108 |
| Minor sub-study placebo | Placebo comparator | N = 15 Receives: Other: Placebo |
| Main sub-study AMG 108 | Active comparator | N = 73 Receives: Drug: Systemic AMG 108 |
| Main sub-study placebo | Placebo comparator | N = 73 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC pain score
Measured: Week 6
Secondary outcomes (3)
Change in WOMAC pain score
Measured: Week 12
Change in WOMAC composite score and function and stiffness index scores
Measured: Weeks 6 and 12
Achieving 50% or more improvement from Day 1 in the WOMAC
Measured: Weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2005
- Study completionNov 2005
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.
- More trials run by AmgenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110942
- Sponsor's protocol ID
- 20040166
- Status last verified
- Jun 2008
- First submitted
- 16 May 2005
- Last updated
- 23 Jun 2008
- Results posted
- No
Publications
Cohen SB, Proudman S, Kivitz AJ, Burch FX, Donohue JP, Burstein D, Sun YN, Banfield C, Vincent MS, Ni L, Zack DJ. A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee. Arthritis Res Ther. 2011 Jul 29;13(4):R125. doi: 10.1186/ar3430.
PubMed 21801403
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Systemic AMG 108 in Subjects With Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT00110942
- Acronym / sponsor ID
- 20040166
- Conditions
- Osteoarthritis
- Keywords
- Intra-articular, Osteoarthritis, OA, anakinra, Amgen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 17 May 2005 (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 clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg subcutaneously [SC] every 4 weeks) in subjects with OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minor sub-study AMG 108 | Active comparator | Drug: Systemic AMG 108N = 15 |
| Minor sub-study placebo | Placebo comparator | Other: PlaceboN = 15 |
| Main sub-study AMG 108 | Active comparator | Drug: Systemic AMG 108N = 73 |
| Main sub-study placebo | Placebo comparator | Other: PlaceboN = 73 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria
- Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
- If currently taking any over the counter nutritional supplements, must be on stable doses for greater than 2 months prior to screening
- If utilizing physical therapy, biomechanical devices or orthotic support, must have been using treatment or device for greater than or equal to 2 months prior to screening
- If currently or previously taking any non-prescribed supplement (e.g., glucosamine or chondroitin sulphate, shark cartilage, diacerein, soya extract, etc.) must be on stable doses for at least 2 months prior to screening
Key exclusion criteria (20 listed)
- Malignancy within the previous 5 years, except for basal cell or in situ cancer
- Significant hematologic disease - Active infection or history of recurrent or chronic infections
- Known diagnosis of HIV, hepatitis B, or hepatitis C infection
- Uncontrolled diabetes or cardiovascular disease and hypertension
- Inflammatory arthropathy including secondary OA
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 |
|---|---|---|
| Systemic AMG 108300 mg SC AMG 108 Q4W for 3 doses | Drug | Main sub-study AMG 108, Minor sub-study AMG 108 |
| PlaceboSC placebo injection Q4W for 3 doses | Other | Main sub-study placebo, Minor sub-study placebo |
Primary outcome
Change in WOMAC pain score
Time frame: Week 6
3 secondary outcomes
Change in WOMAC pain score
Time frame: Week 12
Change in WOMAC composite score and function and stiffness index scores
Time frame: Weeks 6 and 12
Achieving 50% or more improvement from Day 1 in the WOMAC
Time frame: Weeks 6 and 12
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 23 Jun 2008.
- Derived from this study: PubMed 21801403Cohen SB, Proudman S, Kivitz AJ, Burch FX, Donohue JP, Burstein D, Sun YN, Banfield C, Vincent MS, Ni L, Zack DJ. A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee. Arthritis Res Ther. 2011 Jul 29;13(4):R125. doi: 10.1186/ar3430.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Systemic AMG 108 in people with Osteoarthritis, run by Amgen.
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 9 inclusion and 20 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 23 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in WOMAC pain score (time frame: Week 6). 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 NCT00110942, 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 23 Jun 2008.