10 results
Part A:To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeksPart B:• To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24…
In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…
our main objective is to determine whether additional folic acid to ferrous fumarate contributes to the increase of haemoglobin and the improvement of health status in post partum anaemia. Our second objective is to asses what the difference in…
In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…
Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with a response at Week 24 in at least one of the following groups:* Group 1 (>= 18 yr-old)* Group 2 (6 - 17 yr…
Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical
Trial (FACT)
Primary ObjectiveThe overall aim is to evaluate a new preeclampsia (PE) prevention strategy: 4.0mg (1.0mg x 4) of folic acid supplementation vs. placebo from early (80/7 to 166/7 weeks of gestation) pregnancy until delivery.Secondary ObjectivesTo…
The main goal of the proposed project is to compare two MTX dosing regimens to suppress ADA levels in patients with inflammatory bowel disease (IBD) with loss of response to anti-TNF agents, and to relate these findings to clinical and biochemical…
1. To assess the safety, tolerability, and efficacy of ABBV-3373 administered every other week (eow) intravenously (IV) in subjects with moderately to severely active RA on background MTX.2. To compare clinical efficacy of ABBV-3373 with adalimumab…
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…