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Hydroxychloroquine/Atorvastatin in the Treatment of Osteoarthritis (OA) of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01645176
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : May 8, 2017
Last Update Posted : July 13, 2018
Information provided by (Responsible Party):
Mark Genovese, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Hydroxychloroquine/Atorvastatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine/Atorvastatin in the Treatment of OA of the Knee
Study Start Date : May 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Hydroxychloroquine/Atorvastatin open label Drug: Hydroxychloroquine/Atorvastatin
Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Male or female adults age >40 years with a body mass index <35
  3. Radiographic evidence of at least one osteophyte in either knee on posteroanterior (PA) and lateral standing, flexed x-ray.
  4. A Kellegren-Lawrence score of 2-3, or KL score of 1 accompanied by a clinically apparent effusion in the index knee.
  5. A WOMAC pain score of >8 on the index knee at screening visit.

Exclusion Criteria:

  1. A requirement for treatment with high potency opioids for pain relief.
  2. 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.
  3. On an unstable dose of NSAIDs or analgesics for at least 1 months prior to screening visit 1.
  4. Using a handicap assistance device (i.e., cane, walker) >50% of the time.
  5. 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.
  6. 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.
  7. Had joint replacement surgery in the index knee.
  8. 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
  9. 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.
  10. Clinical signs and symptoms of active knee infection or radiographic evidence of crystal disease other than chondrocalcinosis (i.e. gout).
  11. 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
  12. 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
  13. 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.
  14. Significant hip pain, ipsilateral to the index knee that may interfere with assessments of index knee pain
  15. A known or clinically suspected infection with human immunodeficiency virus (HIV), or hepatitis C or B viruses
  16. Participated within 3 months or will participate concurrently in another investigational drug or vaccine study
  17. A history of drug or alcohol dependence or abuse in the past 3 years
  18. 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.
  19. 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.
  20. 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.
  21. Use of fibric acid derivative in past 3 months.
  22. 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.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645176

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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Responsible Party: Mark Genovese, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01645176    
Other Study ID Numbers: 23784
First Posted: July 20, 2012    Key Record Dates
Results First Posted: May 8, 2017
Last Update Posted: July 13, 2018
Last Verified: July 2018
Keywords provided by Mark Genovese, Stanford University:
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents