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- Klinische proef NCT01204138
Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA (CATARA)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The primary objective of this study is to evaluate the efficacy of apremilast when used in combination with a background DMARD and TNF inhibition in patients with active RA using the ACR responder index looking for a 20% improvement.
To evaluate the safety and tolerability of apremilast when used in combination with TNF inhibition in patients with active RA.
To evaluate the clinical outcomes in RA using the individual domains of the ACR responder index1 .
To evaluate the clinical outcomes of RA using the Disease Activity Score (DAS28)2 To investigate the effects of apremilast on change in cytokine plasma concentration levels (from baseline to Week 12) and the achievement of an ACR response
Studietype
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
-
California
-
Stanford, California, Verenigde Staten, 94305
- Stanford University School of Medicine
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form
- 18 years of age at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements
- Must have a diagnosis of RA of at least 6 months duration based on the ACR criteria
- Must have evidence of active disease with DAS-28 > 3.8
May be on one of the following DMARDs for at least 12 weeks and at a stable dose for at least 6 weeks:
- Methotrexate 7.5-25mg/week
- Hydroxychloroquine (200-400mg/day)
Must be on one of the following SQ TNF inhibitors at a stable, label approved dose for at least 12 weeks:
- adalimumab (Humira®, Abbott Laboratories, North Chicago, IL)
- certolizumab pegol (Cimzia®, UCB, Inc, Smyrna, GA)
- golimumab (Simponi®, Johnson & Johnson, New Brunswick, NJ)
- etanercept (Enbrel®, Amgen, Thousand Oaks, CA and Wyeth Pharmaceuticals, Philadelphia, PA)
- Concommitant use of non-steroidal anti-inflammatory drugs and/or oral corticosteroids (prednisone<10mg/day or equivalent) are permitted if doses have been stable for at least 14 days.
- If taking methotrexate, patient must also be taking folic or folinic acid at at dose of no less then 5mg/week.
Must meet the following laboratory criteria:
- Hemoglobin > 9 g/dL
- White blood cell (WBC) count; 3000 /;L (3.0 X 109/L) and 14,000/L (< 14 X 109/L)
- Platelets; 100,000 /L (100 X 109/L)
- Serum creatinine; 1.5 mg/dL (or 133mol/L)
- Total bilirubin; 2.0 mg/dL
- Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]); 1.5x upper limit of normal (ULN)
- Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner while on study. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication and for one month after taking the last dose of study medication.
- Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 28 days after taking the last dose of study medication
Exclusion Criteria:
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Pregnant or breastfeeding
- Systemic fungal infection
- Active tuberculosis or a history of incompletely treated tuberculosis
- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
- Clinically significant abnormality on the chest x-ray (CXR) with anteriorposterior and lateral views at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
- Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
- Any clinically significant abnormality on 12-lead ECG at screening
- History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency [CVID])
- Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
- History of Human Immunodeficiency Virus (HIV) infection
- Antibodies to Hepatitis C at screening
- History of malignancy within 5 years prior to the screening visit (except for treated [i.e. cured] basal cell skin carcinomas and treated [i.e. cured] carcinoma in situ of the cervix)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: placebo
Patient randomized to one of two arms, either placebo, or Apremilast
|
Placebo BID
|
Actieve vergelijker: Apremilast
Patients randomized to either placebo or apremilast
|
Apremilast 30mg BID
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
20% improvement based on ACR responder criteria
Tijdsspanne: 12 weeks
|
12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
ACR 50/70 and DAS
Tijdsspanne: 12 weeks
|
12 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Mark Genovese, Stanford University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Auto-immuunziekten
- Gewrichtsziekten
- Musculoskeletale aandoeningen
- Reumatische aandoeningen
- Bindweefselziekten
- Artritis
- Artritis, reumatoïde
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Fosfodiësteraseremmers
- Fosfodiësterase 4-remmers
- Apremilast
Andere studie-ID-nummers
- SU-08312010-6811
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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