- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00051662
Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
23. juni 2005 opdateret af: XOMA (US) LLC
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)
Studieoversigt
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding
45
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
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
- 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.
Exclusion criteria:
- 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.
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studieafslutning
1. februar 2004
Datoer for studieregistrering
Først indsendt
14. januar 2003
Først indsendt, der opfyldte QC-kriterier
15. januar 2003
Først opslået (Skøn)
16. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juni 2005
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2005
Sidst verificeret
1. september 2004
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUPA600
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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University of AarhusAarhus University HospitalAfsluttetPolyartikulær juvenil reumatoid arthritis | Systemisk juvenil idiopatisk arthritis | Juvenil Idiopatisk Arthritis, OligoarthritisDanmark
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Centocor, Inc.Afsluttet
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Genentech, Inc.Afsluttet
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