Trial Outcomes & Findings for Hydroxychloroquine/Atorvastatin in the Treatment of Osteoarthritis (OA) of the Knee (NCT NCT01645176)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

baseline and 16 weeks

Results posted on

2018-07-13

Participant Flow

Responders to ad in local paper, medical clinic May 2012 - Dec 2014

Osteoarthritis of knee

Unit of analysis: knee

Participant milestones

Participant milestones
Measure	Hydroxychloroquine/Atorvastatin Open Label Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
Overall Study STARTED	21 21
Overall Study COMPLETED	16 16
Overall Study NOT COMPLETED	5 5

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydroxychloroquine/Atorvastatin Open Label Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
Overall Study Lack of Efficacy	4
Overall Study did not complete final MRI	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxychloroquine/Atorvastatin Open Label n=16 Participants Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
Age, Continuous age	64.7 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
WOMAC PAIN	9.8 units on a scale STANDARD_DEVIATION 3.2 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 16 weeks

Population: Participants with osteoarthritis of knee

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.

Outcome measures

Outcome measures
Measure	Osteoarthritis of Knee n=16 Participants Change in MRI synovitis
Change in Synovitis	9.8 units on a scale Standard Deviation 4.4

Adverse Events

Hydroxychloroquine/Atorvastatin Open Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark C. Genovese

Stanford University School of Medicine

Phone: 650-498-4528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place