OsteoarthritisPhase 1/2NCT00686439
Adalimumab for Inflammatory Osteoarthritis
A Phase 1/2 study testing adalimumab in people with Osteoarthritis, run by University of Alberta at 1 site in Canada.
Trial summary
We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Nov 2010
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 40 years of age or older.
- If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
- If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative.
- Patient has a diagnosis of OA of the index knee according to American College of Rheumatology criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3).
- Patient has had continual pain for at least 6 months prior to inclusion in the study. This includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an NSAID, acetaminophen/codeine combination (i.e. Tylenol No 2, 3, 4) taken at least 3 times daily
- Patient has had daily knee pain for the month preceding study enrolment.
- Patient has a summed pain score of 125-400mm (visual analog scale) on the WOMAC pain sub-scale in the index (more symptomatic) knee.
- Patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at Screening and Baseline.
Who cannot join
- Subject has a history of an allergic reaction or significant sensitivity to constituents of Adalimumab.
- Patient has a history of proven systemic arthritis such as rheumatoid arthritis.
- Patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee OA
- Patient has predominant patellofemoral disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis
We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.
Read the detailed description
This is a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. Primary endpoint is at 12 weeks and primary outcome is the OARSI responder index.
- Conditions
- Osteoarthritis
- Being tested
- adalimumab
- Keywords
- osteoarthritis, adalimumab, mri
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabDrug
Also called Humira
subcutaneous injection 40mg on alternate weeks
adalimumabDrug
Also called Humira
subcutaneous injection 40mg every other week
| Study group | Role | What they receive |
|---|---|---|
| adalimumab | Experimental | Not described Receives: Drug: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
OARSI/OMERACT response
Measured: 12 weeks
Secondary outcomes (1)
WOMAC Patient Global MRI
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2010
- Study completionNov 2010
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 University of AlbertaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Maksymowych, University of Alberta
- Investigators
- walter p maksymowych, FRCP, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686439
- Sponsor's protocol ID
- HUM 06-087
- Status last verified
- Jun 2012
- First submitted
- 26 May 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Maksymowych WP, Russell AS, Chiu P, Yan A, Jones N, Clare T, Lambert RG. Targeting tumour necrosis factor alleviates signs and symptoms of inflammatory osteoarthritis of the knee. Arthritis Res Ther. 2012 Oct 4;14(5):R206. doi: 10.1186/ar4044.
PubMed 23036475
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis
- ClinicalTrials.gov ID
- NCT00686439
- Acronym / sponsor ID
- HUM 06-087
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, adalimumab, mri
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 May 2008 (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.
We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.
Detailed description
This is a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. Primary endpoint is at 12 weeks and primary outcome is the OARSI responder index.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adalimumab | Experimental | Drug: adalimumab |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is 40 years of age or older.
- If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
- If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative.
- Patient has a diagnosis of OA of the index knee according to American College of Rheumatology criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3).
- Patient has had continual pain for at least 6 months prior to inclusion in the study. This includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an NSAID, acetaminophen/codeine combination (i.e. Tylenol No 2, 3, 4) taken at least 3 times daily
Key exclusion criteria (4 listed)
- Subject has a history of an allergic reaction or significant sensitivity to constituents of Adalimumab.
- Patient has a history of proven systemic arthritis such as rheumatoid arthritis.
- Patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee OA
- Patient has predominant patellofemoral disease
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 |
|---|---|---|
| adalimumabAlso: Humirasubcutaneous injection 40mg on alternate weeks | Drug | adalimumab |
| adalimumabAlso: Humirasubcutaneous injection 40mg every other week | Drug | adalimumab |
Primary outcome
OARSI/OMERACT response
Time frame: 12 weeks
1 secondary outcome
WOMAC Patient Global MRI
Time frame: 12 weeks
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 14 Jun 2012.
- Derived from this study: PubMed 23036475Maksymowych WP, Russell AS, Chiu P, Yan A, Jones N, Clare T, Lambert RG. Targeting tumour necrosis factor alleviates signs and symptoms of inflammatory osteoarthritis of the knee. Arthritis Res Ther. 2012 Oct 4;14(5):R206. doi: 10.1186/ar4044.
Related trials for Osteoarthritis
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Hybrid Closed Wedge High Tibial Osteotomy
Patello-femoral Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
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.
walter p maksymowych, FRCP principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adalimumab in people with Osteoarthritis, run by University of Alberta at 1 site in Canada.
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 8 inclusion and 4 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 14 Jun 2012. 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 Canada. 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 combined 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.
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?
OARSI/OMERACT response (time frame: 12 weeks). 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 NCT00686439, 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 14 Jun 2012.