Osteoarthritis of the KneePhase 2NCT01645176
Hydroxychloroquine/Atorvastatin in the Treatment of Osteoarthritis (OA) of the Knee
A Phase 2 study testing Hydroxychloroquine/Atorvastatin in people with Osteoarthritis of the Knee, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is to learn about the effects in inflammation and pain in patients with Osteoarthritis of the knee. These medications are FDA approved and commercially available. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Hydroxychloroquine/Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ambulatory subjects with OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. Symptoms must include knee joint pain.
- Male or female adults age >40 years with a body mass index <35
- Radiographic evidence of at least one osteophyte in either knee on posteroanterior (PA) and lateral standing, flexed x-ray.
- A Kellegren-Lawrence score of 2-3, or KL score of 1 accompanied by a clinically apparent effusion in the index knee.
- A WOMAC pain score of >8 on the index knee at screening visit.
Who cannot join
- A requirement for treatment with high potency opioids for pain relief.
- Unwilling to abstain from NSAIDs and/or other analgesic medications except acetaminophen (i.e., COX-2 inhibitors, tramadol) for 48 hours and acetaminophen for 24 hours prior to pain assessments during the study. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
- On an unstable dose of NSAIDs or analgesics for at least 1 months prior to screening visit 1.
- Using a handicap assistance device (i.e., cane, walker) >50% of the time.
- Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening visit 1 and will not remain stable during their participation in the study.
- Had a previous history of arthroscopic or open surgery to the index knee in the past 6 months or planned surgery during study follow up.
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- Had joint replacement surgery in the index knee.
- Received corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening visit 1 and/or not willing to abstain from treatments for the duration of the study
- A history in the past 5-10 years of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
- Clinical signs and symptoms of active knee infection or radiographic evidence of crystal disease other than chondrocalcinosis (i.e. gout).
- A history of abnormal laboratory results >2.5 x ULN indicative of any significant medical disease, which in the opinion of the investigator, would preclude the subjects participation in the study
- Any of the following abnormal laboratory results during screening:
- ALT and/or AST >2.5x ULN
- Hemoglobin <9 g/dL
- WBC <3500 cells/mm3
- Lymphocyte count <1000 cells/mm3
- Serum creatinine >1.5 x ULN or calculated Glomerular filtration rate less than 50.
- Creatine phosphokinase level > 2x ULN
- A history of malignancy in the past ten years (<10 years), with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
- Significant hip pain, ipsilateral to the index knee that may interfere with assessments of index knee pain
- A known or clinically suspected infection with human immunodeficiency virus (HIV), or hepatitis C or B viruses
- Participated within 3 months or will participate concurrently in another investigational drug or vaccine study
- A history of drug or alcohol dependence or abuse in the past 3 years
- A female with reproductive capability who is unwilling to use birth control for the duration of the study and/or intends to conceive within 12 months of dosing.
- Ongoing use of hydroxychloroquine, or any anti-malarial, or prior history of use within past 3 months or any prior history of history of allergy, hypersensitivity or toxicity to antimalarial use.
- Ongoing use of a statin (HMG Co A reductase inhibitor), or use within past 3 months or any prior history of history of allergy, hypersensitivity, or toxicity to statin use.
- Use of fibric acid derivative in past 3 months.
- Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxychloroquine/Atorvastatin in the Treatment of OA of the Knee
The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is to learn about the effects in inflammation and pain in patients with Osteoarthritis of the knee. These medications are FDA approved and commercially available.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Hydroxychloroquine/Atorvastatin
- Keywords
- OA, Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine/AtorvastatinDrug
Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine/Atorvastatin open label | Experimental | Not described Receives: Drug: Hydroxychloroquine/Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Synovitis
MRI readings performed independently by two musculoskeletal radiologists, using a semi-quantitative scoring system based on MRI assessment of knee OASynovitis scored using axial \& sagittal CE-MRI sequence, while effusion \& bone marrow lesions were scored using non-CE-MRI sequences of parent study.
Synovitis defined as enhancing thickened synovium (>2 mm) \& was evaluated at nine sites of joint-medial \& lateral parapatellar recess, suprapateller, infrapatellar, intercondylar, medial \& lateral perimeniscal, \& adjacent to anterior \& posterior cruciate ligaments (ACL/PCL) in all subjects. Synovial thickness was scored semi-quantitatively based on maximal thickness in any slice at each site as follows: grade 0 if <2mm, grade 1 if 2-4 mm \& grade 2 if >4mm. For assessment of whole knee synovitis scores of all sites were summed and categorized: 0-4 normal or equivocal synovitis; 5-8 mild synovitis; 9-12 moderate synovitis \& >/= 13 severe synovitis.
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Genovese, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645176
- Sponsor's protocol ID
- 23784
- Status last verified
- Jul 2018
- First submitted
- 31 May 2012
- Last updated
- 13 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine/Atorvastatin in the Treatment of OA of the Knee
- ClinicalTrials.gov ID
- NCT01645176
- Acronym / sponsor ID
- 23784
- Conditions
- Osteoarthritis of the Knee
- Keywords
- OA, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 8 May 2017
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 of a combination therapy of hydroxychloroquine and atorvastatin is to learn about the effects in inflammation and pain in patients with Osteoarthritis of the knee. These medications are FDA approved and commercially available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine/Atorvastatin open label | Experimental | Drug: Hydroxychloroquine/Atorvastatin |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatory subjects with OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. Symptoms must include knee joint pain.
- Male or female adults age >40 years with a body mass index <35
- Radiographic evidence of at least one osteophyte in either knee on posteroanterior (PA) and lateral standing, flexed x-ray.
- A Kellegren-Lawrence score of 2-3, or KL score of 1 accompanied by a clinically apparent effusion in the index knee.
- A WOMAC pain score of >8 on the index knee at screening visit.
Key exclusion criteria (28 listed)
- A requirement for treatment with high potency opioids for pain relief.
- Unwilling to abstain from NSAIDs and/or other analgesic medications except acetaminophen (i.e., COX-2 inhibitors, tramadol) for 48 hours and acetaminophen for 24 hours prior to pain assessments during the study. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
- On an unstable dose of NSAIDs or analgesics for at least 1 months prior to screening visit 1.
- Using a handicap assistance device (i.e., cane, walker) >50% of the time.
- Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening visit 1 and will not remain stable during their participation in the study.
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 |
|---|---|---|
| Hydroxychloroquine/AtorvastatinHydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day | Drug | Hydroxychloroquine/Atorvastatin open label |
Primary outcome
Change in Synovitis
Time frame: baseline and 16 weeks
MRI readings performed independently by two musculoskeletal radiologists, using a semi-quantitative scoring system based on MRI assessment of knee OASynovitis scored using axial \& sagittal CE-MRI sequence, while effusion \& bone marrow lesions were scored using non-CE-MRI sequences of parent study. Synovitis defined as enhancing thickened synovium (>2 mm) \& was evaluated at nine sites of joint-medial \& lateral parapatellar recess, suprapateller, infrapatellar, intercondylar, medial \& lateral perimeniscal, \& adjacent to anterior \& posterior cruciate ligaments (ACL/PCL) in all subjects. Synovial thickness was scored semi-quantitatively based on maximal thickness in any slice at each site as follows: grade 0 if <2mm, grade 1 if 2-4 mm \& grade 2 if >4mm. For assessment of whole knee synovitis scores of all sites were summed and categorized: 0-4 normal or equivocal synovitis; 5-8 mild synovitis; 9-12 moderate synovitis \& >/= 13 severe synovitis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine/Atorvastatin in people with Osteoarthritis of the Knee, run by Stanford University 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 28 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 13 Jul 2018. 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 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?
Yes. Results are posted in the registry (first posted 8 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Synovitis (time frame: baseline and 16 weeks). 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 13 Jul 2018.