Psoriatic ArthritisPhase 1NCT00051662
Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
A Phase 1 study testing efalizumab in people with Psoriatic Arthritis, run by XOMA (US) LLC.
Trial summary
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA) 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?
- efalizumab
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2004
- 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
- Diagnosed with PsA as defined by:
- Presence of psoriasis with at least one 2 cm plaque AND
- One of the five functional classifications of PsA
- Functional Class I, II, or III as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- Moderate to severe disease, defined as follows:
- At least 3 tender and 3 swollen joints (78 joint count for tenderness and 76 joints for swelling; AND
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- Either ESR ≥ 28 mm/hr, CRP ≥ 1.5 mg/dL, or morning stiffness for ≥ 30 minutes.
- Currently taking at least one of the following systemic therapies for PsA: pre-existing stable doses of NSAIDs, corticosteroids (≤ 10 mg/day), and either sulfasalazine (≤ 3 gm/day) or methotrexate (≥ 7.5 and ≤ 30 mg/week) but not both.
- 18 to 80 years of age.
- Body weight ≤ 125 kg (275 lbs).
- Candidate for systemic immunomodulatory therapy.
- Using an acceptable method of birth control.
- If female, must have a negative serum pregnancy test during screening period, must be surgically sterile, or must be at least five years postmenopausal.
- Informed about the study and signed an informed consent prior to performance of any study-related procedure.
Who cannot join
- Previous treatment with efalizumab.
- Rheumatoid Factor positive without dactylitis or positive X-rays of the hands or feet, or with rheumatoid nodules.
- History of joint replacement surgery within 60 days prior to the start of study drug dosing.
- Joint replacement therapy planned within nine months subsequent to the start of study drug dosing.
- Intra-articular cortisone injections within 28 days prior to the start of study drug dosing.
- Pregnancy or lactation.
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- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 < 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
- Active bacterial, viral, fungal, mycobacterium tuberculosis or atypical mycobacterium infection.
- Positive PPD test unless subject with positive PPD test completed a course of treatment for tuberculosis
- History of any opportunistic infection.
- History of a malignancy within the past five years. Subjects with a history of fully resolved, resected, basal or squamous cell carcinoma may be enrolled.
- Received any vaccine within 28 days prior to the start of study drug dosing.
- Chronic disorders apart from PsA affecting the joints, such as systemic lupus erythematosus, rheumatoid arthritis, gout, scleroderma or known reactive arthritis (e.g., Reiter's syndrome).
- COPD, asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily.
- Failed to respond or maintain response to Enbrel.
- Received any DMARD other than methotrexate or sulfasalazine during the 28 days prior to the start of study drug dosing.
- Approved biologic PsA therapy during the 28 days or seven half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time; Enbrel within 42 days prior to the start of study drug dosing.
- Investigational drug and/or treatment during the 28 days or 7 half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time.
- Any condition which, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to efalizumab.
- Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function (AST or ALT ≥ 2.5
- ULN).
- Serum creatinine level ≥ 1.5 mg/dL
- Platelet count ≤ 125,000 cells/mm3
- WBC count ≤ 3,500 cells/mm3
- Total lymphocyte count ≤ 1000 cells/mm3
- Seropositive for hepatitis B
- Seropositive for hepatitis C antibody
- Seropositive for HIV
- Antinuclear antibodies titer ≥ 1:80
- History of inflammatory bowel disease
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Efficacy and Pharmacokinetics of Efalizumab in Subjects With Psoriatic Arthritis
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA)
Read the detailed description
A phase II, randomized, double-blind, placebo-controlled study to:
- Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with psoriatic arthritis (PsA).
- Evaluate the safety, tolerability and pharmacokinetics of efalizumab in the treatment of subjects with PsA
- Conditions
- Psoriatic Arthritis
- Being tested
- efalizumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2003 (estimated)
- Study completionFeb 2004
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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051662
- Sponsor's protocol ID
- HUPA600
- Status last verified
- Sep 2004
- First submitted
- 14 Jan 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Efficacy and Pharmacokinetics of Efalizumab in Subjects With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00051662
- Acronym / sponsor ID
- HUPA600
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study completion
- Feb 2004
- First posted
- 16 Jan 2003 (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 determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA)
Detailed description
A phase II, randomized, double-blind, placebo-controlled study to:
- Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with psoriatic arthritis (PsA).
- Evaluate the safety, tolerability and pharmacokinetics of efalizumab in the treatment of subjects with PsA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosed with PsA as defined by:
- Functional Class I, II, or III as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- Moderate to severe disease, defined as follows:
- Currently taking at least one of the following systemic therapies for PsA: pre-existing stable doses of NSAIDs, corticosteroids (≤ 10 mg/day), and either sulfasalazine (≤ 3 gm/day) or methotrexate (≥ 7.5 and ≤ 30 mg/week) but not both.
- 18 to 80 years of age.
Key exclusion criteria (30 listed)
- Previous treatment with efalizumab.
- Rheumatoid Factor positive without dactylitis or positive X-rays of the hands or feet, or with rheumatoid nodules.
- History of joint replacement surgery within 60 days prior to the start of study drug dosing.
- Joint replacement therapy planned within nine months subsequent to the start of study drug dosing.
- Intra-articular cortisone injections within 28 days prior to the start of study drug dosing.
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 |
|---|---|---|
| efalizumab | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing efalizumab in people with Psoriatic Arthritis, run by XOMA (US) LLC.
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 14 inclusion and 30 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
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 24 Jun 2005; AzTrials last refreshed its copy on 8 Nov 2026.