35 results
Primary ObjectiveThe primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with methotrexate to methotrexate alone in achieving Remission, defined as SDAI less than or equal to 3, at Week 24.…
Primary: to assess efficacy of weekly subcutaneous (SC) administration of Abatacept vs. placebo on disease activity assessed with ESSDAI at in patients with pSS. Secondary: to assess efficacy of Abatacept on clinical, functional, subjective, and…
* To determine the DLT and the MTD/RP2D of docetaxel as ModraDoc006/ritonavir that can be administered safely to patients with NSCLC in a bi-daily weekly schedule, following platinum doublet first-line treatment.
To determine the effect of a high-fat meal on the exposure to docetaxel given as ModraDoc006 tablets in combination with ritonavir in patients with cancer.
- evaluation of the safety of extended use of ModraDoc006/r - provide longterm access to ModraDoc006/r treatment for patients who have completed a phase I trial with ModraDoc006/r and who might have benefit from longterm treatment with weekly…
The primary objective of this study is to evaluate the effect of multiple doses of azithromycin, clarithromycin and ritonavir on the pharmacokinetics, safety and tolerability of a single oral 150 mg dose of ivacaftor in healthy controls and in…
The aim of this clinical trial is to evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.
The primary aim of this trial is to determine the recommended safe dose and schedule of ModraDoc006/r in castration-resistant prostate cancer (CRPC) patients. The first 5 CRPC patients in this study showed a different pharmacokinetic profile, as…
Primary: 1. Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and CminSecondary objective 1. Safety of the CYP3A4 moderator ritonavir in combination with erlotinib,…
To investigate the effect of CTLA4-Ig (abatacept) on phenotype, transcriptional profile, B cell receptor usage and functional parameters of circulating B cells expressing anti-citrullinated protein antibodies (ACPA) in patients with early,…
The objective of the study is to compare conventional therapy with biological therapy in patients with early rheumatoid arthritis.
The sponsor is developing a biological product (DRL_AB) similar to the approved medicine Orencia®. As part of medical-scientific studies to confirm the similarity of the biological products, the Sponsor wants to compare DRL_AB with EU-approved…
The primary objective is to evaluate whether a switching strategy using adalimumab concentration (TDM) is superior to usual care in rheumatoid arthritis patients failing adalimumab treatment with regard to response rates. The secondary objectives…
Main objective:1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-…
To determine the maximum tolerated dose (MTD) of ModraDoc006/r (as ModraDoc006 10 mg tablets in combination with one tablet of 100 mg ritonavir) that can safely be administered in a bi-daily weekly schedule in combination with high-dose intensity…