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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03054259 |
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Date of registration:
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17/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rituximab Objective Outcome Measures Trial in SLE
ROOTS |
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Scientific title:
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A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus |
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Date of first enrolment:
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September 21, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03054259 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Edward Vital, PhD |
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Address:
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Telephone:
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01133924396 |
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Email:
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e.m.j.vital@leeds.ac.uk |
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Affiliation:
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Name:
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Edward Vital |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults aged at least 18 years old
- Active musculoskeletal SLE defined by inflammatory musculoskeletal pain with either
clinical synovitis, ultrasound tenosynovitis or positive power Doppler in at least 1
joint
- No contraindication to the use of IV methylprednisolone, biosimilar rituximab, or any
other required medications such as antipyretics and antihistamines
- Willing to use appropriate contraception if at risk of pregnancy
- Disease activity that is refractory to hydroxychoroquine, or patients unable to take
hydroxychoroquine due to contra-indication or prior toxicity
Exclusion Criteria:
- • Severe "critical" SLE flare defined as: (i) BILAG 2004 A flare in CNS system; (ii)
BILAG 2004 A flare in the renal system; or (iii) any other SLE manifestation requiring
more immunosuppression than allowed within the protocol in the physician's opinion
- Pregnancy
- Breast Feeding
- Receipt of daily oral glucocorticoids greater than 10mg prednisolone or
equivalent at screening or within the previous 5 days, or change in
glucocorticoid dose in the previous 5 days.
- Receipt of intramuscular or intravenous glucocorticoids within the past 4 weeks
- Receipt of intravenous immunoglobulin, plasma exchange or cyclophosphamide within
the last 3 months
- Rituximab within the past 18 months or other biologic therapies within the past 6
months
- Active infections, including but not limited to the human immunodeficiency virus,
hepatitis B (including prior infection as judged by positive Hepatitis B core
antibody) or hepatitis C
- Serum IgG below the lower limit of the local laboratory range
- Receipt of a live attenuated vaccine within 3 months prior to study enrolment
- History of cancer in the past 5 years except for squamous or basal cell carcinoma
that has been completely excised or treated cervical carcinoma in situ
- In female participants, known history of cervical dysplasia CIN Grade III
cervical high-risk human papillomavirus or abnormal cervical cytology other than
abnormal squamous cells of undetermined significance (ASCUS) within the past 3
years. The patient will be eligible after the condition has resolved (e.g.,
follow-up HPV test is negative or cervical abnormality has been effectively
treated >1 year ago)
- Planned surgery within the study period that is expected to require overnight
hospital admission
- Any other concomitant medical condition that, in the investigator's opinion, or
after discussion with the CI, places the participant at risk by participating in
this study
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus Arthritis
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Intervention(s)
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Drug: Methylprednisolone
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Drug: Normal Saline
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Drug: Rituximab
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Primary Outcome(s)
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Feasibility of trial considering adherence to protocol, completion of all assessments and visits
[Time Frame: 26 weeks]
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Secondary Outcome(s)
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Proportion of patients achieving BILAG-based Composite Lupus Assessment (BICLA)
[Time Frame: 16 weeks]
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Number of serious adverse events
[Time Frame: 26 weeks]
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Proportion of patients achieving SLEDAI responder Index (SRI)
[Time Frame: 16 weeks]
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Secondary ID(s)
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RR15/197
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16/YH/0032
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2015-002688-40
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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