MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE (MEASURE)
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|ClinicalTrials.gov Identifier: NCT03355482|
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus Arthritis||Drug: Methylprednisolone Drug: Placebos||Phase 2|
This will be a six month, double blind, randomized, placebo- controlled trial of subcutaneous methotrexate vs methotrexate plus baseline Depomedrol in patients with SLE and >/= 3 tender and 3 swollen joints in the hands and wrists. Patients who are already taking methotrexate </= 15 mg/week may qualify and will have a >/= 2.5 mg/week dose increase at baseline, receiving subcutaneous dosing whether on oral or sc dosing prior to entry. Those not taking methotrexate at baseline will initiate open label treatment in ascending doses beginning at 15 mg/week. All patients will increase methotrexate weekly up to 25 mg as tolerated or until resolution of arthritis. Decreases are allowed as needed.
After randomization, patients may choose to stop or continue any NSAIDs, hydroxychloroquine, or up to 10 mg prednisone if these were being used at screening. All other lupus-specific treatments or medications will be withdrawn. Optimization of methotrexate dose must be completed by Month 2. If additional immune- suppressive medications or steroids become necessary during the trial, patients remain evaluable for the primary endpoint, which is defined by clinical response regardless of treatment. In secondary analyses of Depomedrol vs. placebo, patients treated with rescue interventions will be censored when comparing changes in mean/median synovitis, osteitis RAMRIS or tendinitis scores in the two treatment groups, and they will be included as non- responders in dichotomous endpoints (SRI-4, BICLA). These analyses will also provide useful data for many of the other endpoints (comparisons of MRI vs joint counts and other measures which are valid regardless of treatment). Thus, although off protocol medications will not be encouraged, they will not require removal from the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE|
|Actual Study Start Date :||April 10, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Depomedrol arm
Patients are treated with new or ascending doses of subcutaneous methotrexate, and receive a single intramuscular dose of Depomedrol (160mg) at baseline.
160mg IM at baseline
Sham Comparator: Placebo arm
Patients are treated with new or ascending doses methotrexate, and receive a single intramuscular placebo injection at baseline.
IM saline injection at baseline
- combined MRI synovitis, osteitis and tendinitis score at 3 months compared to baseline in clinical responders [ Time Frame: 3 months ]the sum of the MRI synovitis, osteitis and tendinitis scores at 3 months will be compared to baseline by paired t test for those patients with a clinical response to the treatment regimen (defined as>/= 50% decrease in tender and swollen joints and disease severity scored as BILAG C or D at the 3 month visit). Each MRI parameter will be scored semi-quantitatively according to the OMERACT RA-MRI scoring system (RAMRIS) on a scale of 0-3, with 0=normal, 1=mild, 2=moderate, 3=severe involvement.
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): NCT03355482
|Contact: Aikaterini Thanou, MD||(405) firstname.lastname@example.org|
|Contact: Lydia Mitchell, LPN||(405) 271-8001 ext 34806||Lydia-Mitchell@omrf.org|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89128|
|Contact: Ewa Olech, MD email@example.com|
|Contact: Edwin Serna, CCRP|