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van CCT (UK)

van CCT (UK)

Optimising adalimumab treatment in psoriasis with concomitant methotrexate.

- candidate number17223
- NTR NumberNTR4499
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-apr-2014
- Secondary IDsProject 2013_346 METC AMC Amsterdam
- Public TitleOptimising adalimumab treatment in psoriasis with concomitant methotrexate.
- Scientific TitleOptimising adalimumab treatment in psoriasis with concomitant methotrexate.
- hypothesisThe drugsurvival in the combination group will be better than the survival in the monotherapy group.
- Healt Condition(s) or Problem(s) studiedPsoriasis
- Inclusion criteria-Have a diagnosis of moderate to severe plaque psoriasis (PASI≥8 at time of screening);
-Is a candidate for the treatment with biologic drugs according to the pertaining guidelines;
-Willing and able to use an adequate contraceptives during the study (all men and pre-menopausal women);
-Adalimumab therapy will be started for the treatment of psoriasis
-Signed informed consent.
- Exclusion criteria-History of significant MTX or adalimumab toxicity, intolerability or contraindication
-Prior treatment with adalimumab
-Age < 18 years;
- Known liver or kidney malfunction
- Alcoholabuse
-Blooddyscrasia like bonemarrowhypoplasia, leukocytopenia, thrombocytopenia or a significant anemia
-Known severe or chronic infections like tuberculosis or HIV
- Ulcers in the oral cavity or known active ulcers in digestive tract
-Pregnant and nursing women.
-Need for live vaccinations
-Other immunosuppressive medication (prednisone, mycofenolaatmofetyl (Cellcept e.g.), ciclosporine (Neoral e.g.), sirolimus (Rapamune), systemic tacrolimus (Prograft e.g.) e.g.)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-mrt-2014
- planned closingdate1-feb-2017
- Target number of participants100
- Interventionsadalimumab versus adalimumab plus methotrexate
- Primary outcomeThe drug survival at one year.
- Secondary outcome-Efficacy expressed as the proportion of patients achieving PASI 75 and 90 at week 13, 25, 37 and 49 and reduction of absolute PASI at these timepoints; -Change in PGA (patient global assessment) and IGA (investigator global assessment); -Average adalimumab serum trough concentrations and ADA titers; -Change in impact on Quality of life (Skindex 29 and DLQI); -Treatment satisfaction (measured by TSQM); -Occurrence of (serious) adverse events; -Patient characteristics (age, gender, ethnicity, BMI, PsA, smoking, alcohol use, disease duration, disease severity by PASI, concomitant medication, naÔve for biologics versus non-naÔve (perhaps specified per biologic), trial medication and potential other co-variates (e.g. genetic polymorphisms).
- Timepointsweek 13, 25, 37 and 49
- Trial web site-
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summary Adalimumab is een waardevolle behandeling voor patiŽnten met matige tot ernstige psoriasis indien andere behandelingen, zoals topicale therapie, fototherapie en systemische middelen hebben gefaald of gecontra-indiceerd zijn. Neutraliserende antidrug anti lichamen (ADA) tegen adalimumab kunnen de werkzaamheid van adalimumab beÔnvloeden en verkorten de drug survival (de duur dat het medicijn werkzaam is). Sommige studies hebben gemeld dat tot 50% van de psoriasis patiŽnten behandeld met adalimumab ADA ontwikkelen. Er zijn aanwijzingen dat methotrexaat de vorming van ADA verminderd. In dit onderzoek wordt onderzocht of de combinatie behandeling van adalimumab en methotrexaat een verbeterde drug survival, verhoogde effectiviteit en een goede tolerantie heeft in vergelijking met adalimumab monotherapie.
- Main changes (audit trail)
- RECORD7-apr-2014 - 29-apr-2014

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