Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus (PRESS)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02842814|
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Other: Drug free Drug: HCQ Drug: GC+HCQ||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From China|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Full withdrawal
Intervention: 'Drug free'.
Other: Drug free
Both Glucocorticoid(GC) and hydroxychloroquine(HCQ) treatment are stopped in stable SLE patients.
Experimental: GC withdrawal
Intervention: 'HCQ' .
Glucocorticoid(GC) treatment is stopped in stable SLE patients. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d
Other Name: Hydroxychloroquine
Experimental: No withdrawal
Intervention: 'GC+HCQ' .
Glucocorticoid(GC) is kept no more than 7.5mg/d. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d.
- Percent of subjects with mild to moderate Lupus flare evaluated by modified SELENA-SLEDAI flare index (SFI) [ Time Frame: 33 weeks ]The SFI includes three elements: the SELENA-SLEDAI score (range 0 ~105, with 0 indicating inactive disease and ); an assessment of new or worsening disease activity, medication changes, and hospitalizations that not captured with the use of the SLEDAI; and the score on the physician's global-assessment (PGA) visual-analogue scale (range, 0 to 3, 1=mild, 2=moderate, 3=severe); Mild to moderate flare by SFI is defined as appearance of one of the following: a change in SLEDAI>3 points but≤12 points; or new onset/worse of cutaneous/ mucosal injury (discoid, photosensitivity, profundus, cutaneous vasculitis, bullous lupus, Nasopharyngeal ulcers), serositis (pleuritis and/or pericarditis), arthritis, SLE associated fever; or the need to increase prednisone dosage to no more than 0.5 mg/kg/day; or the need to add hydroxychloroquine or NSAIDs with no increase in the dose GC; or an increment of PGA ranges from 1.0 to 2.5.
- Percent of subjects with a SELENA-SLEDAI maintaining at <4 points [ Time Frame: 33 weeks ]
- Mean change in PGA [ Time Frame: 33 weeks ]The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity; A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity
- • Percent of subjects with at least one B in any system evaluated with The British Isles Lupus Activity Group (BILAG) scoring system [ Time Frame: 33 weeks ]BILAG includes 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and haematological). A to E scoring is based on the physician's intention to treat: Grade A: treatment requiring any of the following 1) high dose oral glucocorticoids, eg: prednisolone>20mg/day; 2) intravenous pulse glucocorticoids, eg: pulse methylprednisolone ≥ 500 mg；3)systemic immunomodulators (include biologicals, immunoglobulins and plasmapheresis)；4) therapeutic high dose anticoagulation, eg: warfarin INR 3 - 4; Grade B: treatment requiring any of the following treatment:1) low dose oral glucocorticoids, eg: prednisolone ≤ 20mg/day; 2) intramuscular or intra-articular or soft tissue glucocorticoids injection; 3) topical glucocorticoids;4) topical immunomodulators; 5) antimalarials or thalidomide;6) symptomatic therapy; eg: NSAIDs; Grade C: mild disease; Grade D: inactive now but previously affected; Grade E: systems never involved
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): NCT02842814
|Contact: Lidan Zhao, MDemail@example.com|
|Anhui Provincial Hospital||Recruiting|
|Hefei, Anhui, China, 230001|
|Contact: Zhu Chen, MD firstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Lidan Zhao, MD email@example.com|
|Xiangya Hospital of Central South University||Recruiting|
|Changsha, Hunan, China, 410008|
|Contact: Hui Luo, MD firstname.lastname@example.org|
|Shengjing Hospital of China Medical University||Recruiting|
|Shenyang, Liaoning, China, 110004|
|Contact: Jingjing Xu, MD email@example.com|
|People's Hospital of Xinjiang Uygur Autonomous Region||Recruiting|
|Urumqi, Xinjiang, China, 830001|
|Contact: Cainan Luo, MD firstname.lastname@example.org|
|Principal Investigator:||Xuan Zhang, MD||Peking Union Medical College Hospital|
|Study Chair:||Xuan Zhang, MD||Peking Union Medical College Hospital|