No registrations found.
ID
Source
Brief title
Health condition
Moderate to severe psoriasis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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, naïve for biologics versus non-naïve (perhaps specified per biologic), trial medication and potential other co-variates (e.g. genetic polymorphisms).
Background summary
Adalimumab is een waardevolle behandeling voor patiënten 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 beïnvloeden en verkorten de drug survival (de duur dat het medicijn werkzaam is). Sommige studies hebben gemeld dat tot 50% van de psoriasis patiënten 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.
Study objective
The drugsurvival in the combination group will be better than the survival in the monotherapy group.
Study design
week 13, 25, 37 and 49
Intervention
adalimumab versus adalimumab plus methotrexate
A0-130
Meibergdreef 9
S.P. Menting
Amsterdam 1105 AZ
The Netherlands
+31 20-5668350
s.p.menting@amc.uva.nl
A0-130
Meibergdreef 9
S.P. Menting
Amsterdam 1105 AZ
The Netherlands
+31 20-5668350
s.p.menting@amc.uva.nl
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.)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4359 |
| NTR-old | NTR4499 |
| Other | METC AMC Amsterdam : Project 2013_346 |