Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
6. maj 2014 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Trials with a new, first -in-class drug will be done to ascertain safety, tolerability, and to explore efficacy in the treatment of rheumatoid arthritis, including its effects on biomarkers.
Approximately 240 adult patients with rheumatoid arthritis despite the use of methotrexate therapy will be recruited for the study.
They will be randomly assigned to one of 4 treatment arms; each patient has an equal chance of receiving the placebo, or 100 mg, 200 mg, 300 mg dose of RWJ-445380.
Patients will take the medication daily for up to 12 weeks.
Patients will receive study medication in a blinded fashion, i.e. the patient, the doctor and the study sponsor will not know what group the patient is in until all patients complete the study.
The investigator and the sponsor will monitor the study for the occurrence of possible side effects.
In addition to a screening visit, patients will have visits every week for the first 2 weeks then every 2 weeks until 12 weeks of treatment.
After 12 weeks, there will be a followup visit 4 weeks after the last dose of study drug is taken.
Medical history, physical examination, blood pressure, heart rate, temperature, and ECGs are checked periodically.
Joints will be assessed to explore whether the drug might affect tender and swollen joints.
Blood samples will be taken for standard safety laboratory tests as well as special tests of the drug blood level, biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation, and other markers for rheumatoid arthritis.
Samples will also be taken to see whether certain types of immune cells are affected by taking the drug.
Immunization with tetanus vaccine will be done to see if taking the drug might affect immune responses to this agent Patients will receive RWJ-445380, 100, 200, 300 mg, or placebo.
Patients will receive oral capsules daily for up to 12 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
259
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina
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Ciudad Autónoma De Buenos Aires, Argentina
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Federal, Argentina
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Lujan, Argentina
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Curitiba, Brasilien
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Porto Alegre, Brasilien
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Sao Paulo, Brasilien
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Alabama
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Birmingham, Alabama, Forenede Stater
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Huntsville, Alabama, Forenede Stater
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Arizona
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Tucson, Arizona, Forenede Stater
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California
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Fair Oaks, California, Forenede Stater
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Whittier, California, Forenede Stater
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Connecticut
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Waterbury, Connecticut, Forenede Stater
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Florida
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Sarasota, Florida, Forenede Stater
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Illinois
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Morton Grove, Illinois, Forenede Stater
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Springfield, Illinois, Forenede Stater
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Maryland
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Frederick, Maryland, Forenede Stater
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Pennsylvania
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Duncansville, Pennsylvania, Forenede Stater
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Tennessee
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Nashville, Tennessee, Forenede Stater
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Texas
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Austin, Texas, Forenede Stater
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Ciudad De Mexico, Mexico
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Guadalajara, Mexico
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Mexico, Mexico
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San Luis Potosi, Mexico
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Bialystok, Polen
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Bydgoszcz, Polen
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Krakow, Polen
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Lublin, Polen
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Poznan, Polen
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Szczecin, Polen
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Warszawa, Polen
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Brno, Tjekkiet
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Plzeò 1, Tjekkiet
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Praha 1, Tjekkiet
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Praha 2, Tjekkiet
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Uherske Hradiste, Tjekkiet
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Zlin, Tjekkiet
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Bad Abbach, Tyskland
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Bad Nauheim, Tyskland
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Dresden, Tyskland
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Essen, Tyskland
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Frankfurt, Tyskland
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Herne, Tyskland
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Leipzig, Tyskland
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints
- methotrexate treatment for 6 months
- at least 10mg/wk and stable dose for at least 8 weeks
- negative TB screening
Exclusion Criteria:
- Use of other disease-modifying anti-rheumatic drugs (DMARDs) (other than Methotrexate MTX)
- previous use of more than 1 anti-TNF (tumor necrosis factor) agent
- previous use of cytotoxics, p38 MAPkinase inhibitor, anti-CD4 antibody
- receipt of live vaccine within 1 month of study drug
- serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection
- other clinically significant disease of other organ system
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: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo
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Placebo once daily for up to 12 weeks
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Eksperimentel: RWJ-445380 100 mg
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RWJ-445380 100 mg once daily for up to 12 weeks
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Eksperimentel: RWJ-445380 200 mg
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RWJ-445380 200 mg once daily for up to 12 weeks
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Eksperimentel: RWJ-445380 300 mg
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RWJ-445380 300 mg once daily for up to 12 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory and physical exam and ECGs in patients with rheumatoid arthritis
Tidsramme: up to 12 weeks
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up to 12 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers
Tidsramme: 12 weeks, Explore effectiveness of drug through accepted clinical measures and biomarkers
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12 weeks, Explore effectiveness of drug through accepted clinical measures and biomarkers
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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
Studiestart
1. december 2006
Primær færdiggørelse (Faktiske)
1. januar 2008
Studieafslutning (Faktiske)
1. januar 2008
Datoer for studieregistrering
Først indsendt
19. januar 2007
Først indsendt, der opfyldte QC-kriterier
19. januar 2007
Først opslået (Skøn)
22. januar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR012511
- C-2006-009 (Anden identifikator: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
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