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Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis (RA PLUS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01132118
First received: May 25, 2010
Last updated: September 2, 2014
Last verified: September 2014
Results First Received: August 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Rheumatoid Arthritis
Insulin Resistance
Intervention: Drug: Hydroxychloroquine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
107 potentially eligible RA patients were screened during 2010-2011. 7 subjects did not meet inclusion/exclusion criteria at screening and 63 declined participation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
37 subjects were initially consented, 7 withdrew consent before randomization. Thirty patients were randomized. Five patients withdrew consent after randomization and two patients stopped participation in the study due to non-serious adverse events.

Reporting Groups
  Description
HCQ Then Placebo

This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.

Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg.

Placebo Then HCQ

This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.

Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg.


Participant Flow for 2 periods

Period 1:   First Intervention (8 Weeks)
    HCQ Then Placebo     Placebo Then HCQ  
STARTED     15     15  
COMPLETED     12     12  
NOT COMPLETED     3     3  
Adverse Event                 1                 0  
Withdrawal by Subject                 2                 3  

Period 2:   Second Intervention (8 Weeks)
    HCQ Then Placebo     Placebo Then HCQ  
STARTED     12     12  
COMPLETED     12     11  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who were randomized to receive either HCQ or placebo.

Reporting Groups
  Description
HCQ Then Placebo

This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.

Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg.

Placebo Then HCQ

This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.

Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg.

Total Total of all reporting groups

Baseline Measures
    HCQ Then Placebo     Placebo Then HCQ     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 14     57  ± 14     56.5  ± 11  
Gender  
[units: participants]
     
Female     13     14     27  
Male     2     1     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insulin Sensitivity Index   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   HOMA-IR   [ Time Frame: Baseline and Week 8 ]

3.  Secondary:   HOMA-B   [ Time Frame: Baseline and Week 8 ]

4.  Secondary:   Total Cholesterol   [ Time Frame: Baseline and Week 8 ]

5.  Secondary:   LDL Cholesterol   [ Time Frame: Baseline and Week 8 ]

6.  Secondary:   HDL Cholesterol   [ Time Frame: Baseline and Week 8 ]

7.  Secondary:   Triglycerides   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daniel H. Solomon
Organization: Brigham and Women's Hospital
phone: 617-525-8127
e-mail: dsolomon@partners.org


Publications:

Publications automatically indexed to this study:

Responsible Party: Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01132118     History of Changes
Other Study ID Numbers: 2009P001926, R21AR057924
Study First Received: May 25, 2010
Results First Received: August 8, 2014
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board