Psoriatic ArthritisPhase 1NCT00509678
Rituxan With or Without Methotrexate in Psoriatic Arthritis
A Phase 1 study testing Rituximab in people with Psoriatic Arthritis, run by Swedish Medical Center at 4 sites in United States.
Trial summary
The purpose of this study is to help determine the effectiveness of rituxan (with or without methotrexate) in the treatment of psoriatic arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2006to Mar 2010
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active disease of at least 6 months duration.
- Receiving treatment on an outpatient basis.
- The patient will have at least one evaluable skin plaque, 2 cm in diameter, that can be followed with a target lesion score (scalp and groin lesions cannot be used).
- Presence of PsA per the CASPAR categories: Psoriasis, Nail Changes, Negative RF test, Dactylitis or radiological evidence of juxta-articular new bone formation.
- Subjects will have greater than or equal to 3 tender (out of 68 joints) and 3 swollen (out of 66) joints at screening and baseline.
Who cannot join
- History of malignancy other than resolved squamous or basal cell or cervical carcinoma
- Presence of a significant medical illness that, in the opinion of the investigator, would potentially compromise the subject's ability to participate in the trial
- Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response
- History or presence of HIV
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of recurrent significant infection or history of recurrent bacterial infections
Show all 18Show fewer
- Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- History of psychiatric disorder that, in the judgment of the investigator, would make the patient inappropriate for entry into this trial or would lead to poor compliance.
- Concurrent treatment with any DMARD (except for MTX), any anti-TNF alpha therapy or other biologic therapy. Topical medications to treat psoriasis are limited to class VI and VII low potency steroids to the palms, soles of the feet, axilla and groin only.
- Concurrent treatment with any DMARD (except for MTX), any anti-TNF alpha therapy or other biologic therapy. Topical medications to treat psoriasis are limited to class VI and VII low potency steroids to the palms, soles of the feet, axilla and groin only.
- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer).
- Previous treatment with any cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19).
- Previous treatment within 6 months with i.v. gamma-globulin, Orencia, toclizumab, natalizumab or Prosorba Column.
- Intra-articular or parental corticosteroid injections within 4 weeks prior to screening.
- Previous treatment with rituximab (MabThera/Rituxan)
- Immunization with a vaccine within 4 weeks prior to randomization (e.g.; MMR, Varivax, Smallpox).
- One intra-articular steroid joint injection is allowed, affected joint is excluded from assessment thereafter.
- Subjects should not take analgesics within 12 hours prior to joint assessments
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of California, San Diego
La Jolla, California, 92037-0943
University of Rochester
Rochester, New York, 14642
Swedish Rheumatology Research
Seattle, Washington, 98104
Stanford University
Stanford, California, 94305-5350
About this study
Official title: Phase IB, Investigator-Initiated, Open-Label, Multi-Center Trial of Rituximab With or Without Methotrexate In Subjects With Psoriatic Arthritis and Psoriasis
The purpose of this study is to help determine the effectiveness of rituxan (with or without methotrexate) in the treatment of psoriatic arthritis.
Read the detailed description
The purpose of this study is to evaluate safety and efficacy of rituximab, with and without methotrexate, in joints, enthesium and skin in psoriatic arthritis patients with inadequate response to methotrexate who have either not tried anti-TNF therapy or have had inadequate or failed response to anti-TNF therapy. To explore biologic mechanism of action via histological and immunohistochemical evaluation of pre and post treatment biopsies of psoriatic plaques.
- Conditions
- Psoriatic Arthritis
- Being tested
- Rituximab
- Keywords
- Rituximab, Rituxan, Psoriatic Arthritis, Arthritis
- Medical subject headings
- Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression.
Measured: followed out for one year from last dose
Secondary outcomes (1)
The exploration of efficacy of rituximab in PsA will be determined by using the week 24 ACR 20 measurement as modified for PsA using 68/66 tender/swollen joint count.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startDec 2006
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Philip J Mease, MD, Principal investigator, Seattle Rheumatology Associates/ Swedish Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509678
- Sponsor's protocol ID
- U3081n
- Status last verified
- Jan 2012
- First submitted
- 27 Jul 2007
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB, Investigator-Initiated, Open-Label, Multi-Center Trial of Rituximab With or Without Methotrexate In Subjects With Psoriatic Arthritis and Psoriasis
- ClinicalTrials.gov ID
- NCT00509678
- Acronym / sponsor ID
- U3081n
- Conditions
- Psoriatic Arthritis
- Keywords
- Rituximab, Rituxan, Psoriatic Arthritis, Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 31 Jul 2007 (estimated)
- 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.
The purpose of this study is to help determine the effectiveness of rituxan (with or without methotrexate) in the treatment of psoriatic arthritis.
Detailed description
The purpose of this study is to evaluate safety and efficacy of rituximab, with and without methotrexate, in joints, enthesium and skin in psoriatic arthritis patients with inadequate response to methotrexate who have either not tried anti-TNF therapy or have had inadequate or failed response to anti-TNF therapy. To explore biologic mechanism of action via histological and immunohistochemical evaluation of pre and post treatment biopsies of psoriatic plaques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active disease of at least 6 months duration.
- Receiving treatment on an outpatient basis.
- The patient will have at least one evaluable skin plaque, 2 cm in diameter, that can be followed with a target lesion score (scalp and groin lesions cannot be used).
- Presence of PsA per the CASPAR categories: Psoriasis, Nail Changes, Negative RF test, Dactylitis or radiological evidence of juxta-articular new bone formation.
- Subjects will have greater than or equal to 3 tender (out of 68 joints) and 3 swollen (out of 66) joints at screening and baseline.
Key exclusion criteria (18 listed)
- History of malignancy other than resolved squamous or basal cell or cervical carcinoma
- Presence of a significant medical illness that, in the opinion of the investigator, would potentially compromise the subject's ability to participate in the trial
- Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response
- History or presence of HIV
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
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 |
|---|---|---|
| RituximabAlso: Rituxan1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. | Drug | – |
Primary outcome
Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression.
Time frame: followed out for one year from last dose
1 secondary outcome
The exploration of efficacy of rituximab in PsA will be determined by using the week 24 ACR 20 measurement as modified for PsA using 68/66 tender/swollen joint count.
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
Philip J Mease, MD principal investigator
Seattle Rheumatology Associates/ Swedish Research Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rituximab in people with Psoriatic Arthritis, run by Swedish Medical Center at 4 sites in United States.
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 18 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: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression. (time frame: followed out for one year from last dose). 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 18 Jan 2012.