Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial

Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1?year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn?s disease or ulcerative colitis who have achieved clinical remission for ?6?months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1?year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission. Clinical trial reference number: EudraCT 2015-001410-1

MEGARA, the R=6000-20000 IFU and MOS of GTC

MEGARA is the new generation IFU and MOS optical spectrograph built for the 10.4m Gran Telescopio CANARIAS (GTC). The project was developed by a consortium led by UCM (Spain) that also includes INAOE (Mexico), IAA-CSIC (Spain) and UPM (Spain). The instrument arrived to GTC on March 28th 2017 and was successfully integrated and commissioned at the telescope from May to August 2017. During the on-sky commissioning we demonstrated that MEGARA is a powerful and robust instrument that provides on-sky intermediate-to-high spectral resolutions RFWHM ~ 6,000, 12,000 and 20,000 at an unprecedented efficiency for these resolving powers in both its IFU and MOS modes. The IFU covers 12.5 x 11.3 arcsec 2 while the MOS mode allows observing up to 92 objects in a region of 3.5 x 3.5 arcmin 2 . In this paper we describe the instrument main subsystems, including the Folded-Cassegrain unit, the fiber link, the spectrograph, the cryostat, the detector and the control subsystems, and its performance numbers obtained during commissioning where the fulfillment of the instrument requirements is demonstrated. © 2018 SPIE

First scientific observations with MEGARA at GTC

On June 25th 2017, the new intermediate-resolution optical IFU and MOS of the 10.4-m GTC had its first light. As part of the tests carried out to verify the performance of the instrument in its two modes (IFU and MOS) and 18 spectral setups (identical number of VPHs with resolutions R=6000-20000 from 0.36 to 1 micron) a number of astronomical objects were observed. These observations show that MEGARA@GTC is called to fill a niche of high-throughput, intermediateresolution IFU and MOS observations of extremely-faint narrow-lined objects. Lyman-α absorbers, star-forming dwarfs or even weak absorptions in stellar spectra in our Galaxy or in the Local Group can now be explored to a new level. Thus, the versatility of MEGARA in terms of observing modes and spectral resolution and coverage will allow GTC to go beyond current observational limits in either depth or precision for all these objects. The results to be presented in this talk clearly demonstrate the potential of MEGARA in this regard