Systemic Lupus Erythematosus ArthritisPhase 2ROOTSNCT03054259
Rituximab Objective Outcome Measures Trial in SLE
A Phase 2 study testing Rituximab, Methylprednisolone and Normal Saline in people with Systemic Lupus Erythematosus Arthritis, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This is a feasibility study to test a new trial design for an important drug in Systemic Lupus Erythematosus (SLE or "lupus"). SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of the body may be affected, but most commonly lupus causes a rash and arthritis, this affects… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Systemic Lupus Erythematosus Arthritis
- What is being tested?
- Rituximab, Methylprednisolone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2017to Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country.
James Goulding, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Chapel Allerton Hospital- Leeds Institute for Rheumatic and Musculoskeletal Medicine
Leeds, West Yorkshire, LS7 4SA
Edward Vital
About this study
Official title: A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus
This is a feasibility study to test a new trial design for an important drug in Systemic Lupus Erythematosus (SLE or "lupus").
SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of the body may be affected, but most commonly lupus causes a rash and arthritis, this affects patients' quality of life.
Read more
Lupus is usually treated with steroids or drugs that suppress the immune system. Although these help, many patients don't respond well enough and there is also concern for long term side effects. There is a new type of treatment called biologics. These target individual cells or molecules rather than the whole immune system and may be more effective with fewer side-effects. B cells are a part of the immune system that are known to play a role in lupus. There is already a biologic that removes these, called rituximab. In rheumatoid arthritis and vasculitis (similar to lupus), rituximab has been proven to be effective in clinical trials. However, in lupus clinical trials it did not seem to show any benefit. But many doctors and patients found that rituximab is effective, but the trials couldn't show this because of the way the drug's effects were measured. Therefore it is important that we test whether it truly is effective for lupus.
In this 6 month clinical study the investigators will look at lupus patients who have skin disease and arthritis as these are very common and randomise them to receive either rituximab or a placebo. Patients will have a careful clinical examination and undergo different methods to measure the effectiveness of the treatment. There are new versions to rituximab called "biosimilars". In this study biosimilar GP2013 will be used.
If this trial is successful a larger definitive study will be designed based on its results.
- Conditions
- Systemic Lupus Erythematosus Arthritis
- Being tested
- Rituximab, Methylprednisolone, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
1000mg rituximab infusions on days 1 and 15 (monoclonal antibody)
100mg infusion on days 1 and 15
Normal SalineDrug
250ml infusion on days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 2 x 1000mg Rituximab and 100mg methylprednisolone Receives: Drug: Rituximab; Drug: Methylprednisolone; Drug: Normal Saline |
| Control | Placebo comparator | 2 x 100mg methylprednisolone plus placebo Receives: Drug: Methylprednisolone; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of trial considering adherence to protocol, completion of all assessments and visits
Overall feasibility of the trial will be judged based on the feasibility variables. It is acknowledged that this trial incorporates multiple inter-related aspects of design, with many possible modifications in trials derived from it. Hence these numbers will be used as a guide only and specific target values have not been defined.
Measured: 26 weeks
Secondary outcomes (3)
Proportion of patients achieving BILAG-based Composite Lupus Assessment (BICLA)
An assesment of clinical efficacy of treatment
Measured: 16 weeks
Proportion of patients achieving SLEDAI responder Index (SRI)
An assesment of clinical efficacy of treatment
Measured: 16 weeks
Number of serious adverse events
Safety assessment
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start21 Sep 2017
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054259
- Sponsor's protocol ID
- RR15/197
- Other IDs
- 2015-002688-40, 16/YH/0032, 2015
- Acronym
- ROOTS
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2017
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03054259
- Acronym / sponsor ID
- ROOTS / RR15/197
- Conditions
- Systemic Lupus Erythematosus Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study to test a new trial design for an important drug in Systemic Lupus Erythematosus (SLE or "lupus").
SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of the body may be affected, but most commonly lupus causes a rash and arthritis, this affects patients' quality of life.
Lupus is usually treated with steroids or drugs that suppress the immune system. Although these help, many patients don't respond well enough and there is also concern for long term side effects. There is a new type of treatment called biologics. These target individual cells or molecules rather than the whole immune system and may be more effective with fewer side-effects. B cells are a part of the immune system that are known to play a role in lupus. There is already a biologic that removes these, called rituximab. In rheumatoid arthritis and vasculitis (similar to lupus), rituximab has been proven to be effective in clinical trials. However, in lupus clinical trials it did not seem to show any benefit. But many doctors and patients found that rituximab is effective, but the trials couldn't show this because of the way the drug's effects were measured. Therefore it is important that we test whether it truly is effective for lupus.
In this 6 month clinical study the investigators will look at lupus patients who have skin disease and arthritis as these are very common and randomise them to receive either rituximab or a placebo. Patients will have a careful clinical examination and undergo different methods to measure the effectiveness of the treatment. There are new versions to rituximab called "biosimilars". In this study biosimilar GP2013 will be used.
If this trial is successful a larger definitive study will be designed based on its results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Rituximab, Drug: Methylprednisolone, Drug: Normal Saline2 x 1000mg Rituximab and 100mg methylprednisolone |
| Control | Placebo comparator | Drug: Methylprednisolone, Drug: Normal Saline2 x 100mg methylprednisolone plus placebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab1000mg rituximab infusions on days 1 and 15 (monoclonal antibody) | Drug | Intervention |
| Methylprednisolone100mg infusion on days 1 and 15 | Drug | Control, Intervention |
| Normal Saline250ml infusion on days 1 and 15 | Drug | Control, Intervention |
Primary outcome
Feasibility of trial considering adherence to protocol, completion of all assessments and visits
Time frame: 26 weeks
Overall feasibility of the trial will be judged based on the feasibility variables. It is acknowledged that this trial incorporates multiple inter-related aspects of design, with many possible modifications in trials derived from it. Hence these numbers will be used as a guide only and specific target values have not been defined.
3 secondary outcomes
Proportion of patients achieving BILAG-based Composite Lupus Assessment (BICLA)
Time frame: 16 weeks
Proportion of patients achieving SLEDAI responder Index (SRI)
Time frame: 16 weeks
Number of serious adverse events
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Goulding, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Methylprednisolone and Normal Saline in people with Systemic Lupus Erythematosus Arthritis, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward Vital, PhD (01133924396, e.m.j.vital@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of trial considering adherence to protocol, completion of all assessments and visits (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.