Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support Program

The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the German Patient Support Program (PSP) and of whom a pregnancy report and pregnancy outcome report is available.
The secondary objectives of this study are applicable for a subpopulation of the above-mentioned population, i.e. for participants of whom data on a standardized questionnaire collected during a telephone interview is available.

Start Date30 Apr 2021

Sponsor / Collaborator

Biogen, Inc.

NCT00299962 / CompletedPhase 1IIT

A Phase I Clinical Trial of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-beta (BG00001, Ad.hIFN-β for Pleural Malignancies

This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:
malignant pleural mesothelioma, or
pleural effusions who have progressed through at least one prior therapy or have refused therapy
BG00001 is given twice through a catheter in the pleural space.

Start Date01 Mar 2006

Sponsor / Collaborator

University of Pennsylvania

[+2]

NCT00107861 / CompletedPhase 1/2

A Phase I/II Study of Interferon-Beta Gene Transfer (Ad.hIFN-β) in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases

This study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases. The purposes of the study are:
to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β;
help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die.

Start Date01 May 2005

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Interferon beta gene therapy(Biogen, Inc.)

100 Translational Medicine associated with Interferon beta gene therapy(Biogen, Inc.)

100 Patents (Medical) associated with Interferon beta gene therapy(Biogen, Inc.)

579

Literatures (Medical) associated with Interferon beta gene therapy(Biogen, Inc.)

01 May 2024·Multiple Sclerosis and Related Disorders

Burden of treatment and quality of life in relapsing remitting multiple sclerosis patients under early high efficacy therapy in Argentina: Data from the Argentinean registry

Article

Author: Cristiano, Edgardo ; Tavolini, Dario ; Alonso, Ricardo ; Carnero Contentti, Edgar ; Burgos, Marcos ; Rojas, Juan I ; Patrucco, Liliana ; Federico, Belén

The objective of this study was to describe and compare the burden of treatment (BOT) and the quality of life (QoL) in early high efficacy therapy (HET) vs. escalation therapy in relapsing remitting multiple sclerosis (RRMS) patients included in RelevarEM, the Argentinean registry of MS (RelevarEM, NCT 03,375,177).METHODScross sectional study conducted between September and December 2022. Participating patients were adults, RRMS patients who initiated (during the last three years) their treatment with a HET (natalizumab, ocrelizumab, alemtuzumab, cladribine) or with escalation treatment (beta interferon, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod). Clinical and demographic aspect were collected. QoL and BOT was measured with the validated to Spanish MusiQol and BOT questionnaire. Propensity score (PS)-based nearest-neighbor matching was applied to homogenize groups. Comparisons were be done using a linear regression analysis model stratified by matched pairs, with BOT and QoL assessments as main outcomes.RESULTS269 patients were included in the analysis, mean age 33.7 ± 5.7 years, 193 (71.7 %) were female. A total of 136 patients were on early HET while 133 were on escalation therapy. In the entire group the mean total BOT score (±SD) was 48.5 ± 15.3 while in the group of patients receiving early HET we observed that the mean BOT score (±SD) was 43.5 ± 12.2 vs. 54.3 ± 13.3 in escalation treatment (p < 0.0001). Regarding the score QoL (±SD), in the entire sample we observed a global score of 77.4 ± 11.2. When we stratified groups, in HET (±SD) it was 81.3 ± 14 vs. 74.1 ± 18.3 in escalation therapy (p = 0.0003).CONCLUSIONin this multicenter study that included 269 patients from Argentina we observed in early HET a significantly lower BOT and higher QoL than patients receiving escalation therapy.

01 Jan 2024·Therapeutic Advances in Neurological Disorders

Treatment switches of disease-modifying therapies in people with multiple sclerosis: long-term experience from the German MS Registry

Article

Author: Krefting, Dagmar ; Peters, Melanie ; Paul, Friedemann ; Frahm, Niklas ; Schirduan, Ksenija ; Lüftenegger, Daniel ; Stahmann, Alexander ; Schaak, Tom P. A. ; Flachenecker, Peter ; Ellenberger, David ; Salmen, Hans C. ; Warnke, Clemens ; Fneish, Firas ; Kleinschnitz, Christoph ; Zettl, Uwe K.

Background: The spectrum of disease-modifying therapies (DMTs) for people with multiple sclerosis (PwMS) has expanded over years, but data on treatment strategies is largely lacking. DMT switches are common clinical practice. Objective: To compare switchers and non-switchers, characterize the first DMT switch and identify reasons and predictors for switching the first DMT. Methods: Data on 2722 PwMS from the German MS Registry were retrospectively analyzed regarding sociodemographic/clinical differences between 1361 switchers (PwMS discontinuing the first DMT) and non-switchers matched according to age, sex, and observation period. Frequencies of first and second DMTs were calculated and switch reasons identified. Predictors for DMT switches were revealed using univariable and multivariable regression models. Results: Switchers and non-switchers differed significantly regarding time to first DMT, education, calendar period of the first DMT start (2014–2017 versus 2018–2021), first DMT class used [mild-to-moderate efficacy (MME) versus high-efficacy (HE) DMT], time on first DMT, and disease activity at first DMT start or cessation/last follow-up. The majority of PwMS started with MME DMTs (77.1%), with the most common being glatiramer acetate, dimethyl/diroximel fumarate, and beta-interferon variants. Switchers changed treatment more often to HE DMTs (39.6%), most commonly sphingosine-1-phosphate receptor modulators, anti-CD20 monoclonal antibodies, and natalizumab. Fewer PwMS switched to MME DMTs (35.9%), with the most common being dimethyl/diroximel fumarate, teriflunomide, or beta-interferon. Among 1045 PwMS with sufficient data (76.8% of 1361 switchers), the most frequent reasons for discontinuing the first DMT were disease activity despite DMT (63.1%), adverse events (17.1%), and patient request (8.3%). Predictors for the first DMT switch were MME DMT as initial treatment [odds ratio (OR) = 2.83 (1.76–4.61), p < 0.001; reference: HE DMT], first DMT initiation between 2014 and 2017 [OR = 11.55 (6.93–19.94), p < 0.001; reference: 2018–2021], and shorter time on first DMT [OR = 0.22 (0.18–0.27), p < 0.001]. Conclusion: The initial use of MME DMTs was among the strongest predictors of DMT discontinuation in a large German retrospective MS cohort, arguing for the need for prospective treatment strategy trials, not only but also on the initial broad use of HE DMTs in PwMS.

01 Sep 2023·Taiwanese journal of obstetrics & gynecology

Vaginal health and quality of sexual life of postmenopausal women on hyaluronic acid and Biosaccharide Gum-1 vaginal gel.

Article

Author: Mazza, Gabriele ; Bruno, Maria Teresa ; Palermo, Gaia ; Caruso, Giuseppe ; Boemi, Sara ; Caruso, Salvatore

OBJECTIVETo evaluate the efficacy of daily vaginal gel containing hyaluronic acid (HA) and Biosaccharide Gum-1 (BG-1) on vulvovaginal atrophy (VVA) and on sexual function and quality of life (QoL).MATERIALS AND METHODSOne hundred-four postmenopausal women with VVA were enrolled in the nonrandomized comparison cohort study. Of them, 50 women on HA/BG-1 participated in the study group and 54 women on lubricants/moisturizers on-demand as a control group. The primary endpoint was the efficacy of the vaginal gel on VVA evaluated by the Vaginal Health Index (VHI) score. Secondary endpoints included sexual behavior by the self-administered female sexual function index (FSFI) questionnaire, and quality of life (QoL), by the Short Form-36 questionnaire (SF-36).RESULTSAll symptoms of AVV improved after 12 weeks of treatment in women on HA/BG-1. The VMI, although improved at the 12-week follow-up compared to baseline, it connoted a low estrogenic stimulation value. Sexual function improved significantly in women on HA/BG-1. Moreover, women reported a significant improvement in the somatic aspects of QoL. No benefits were obtained by the women in the control group.CONCLUSIONSTreatment with HA/BG-1 could have used in postmenopausal women who complain of vaginal dryness. The amelioration of VVA-related signs could improve sexual function and QoL.

100 Deals associated with Interferon beta gene therapy(Biogen, Inc.)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Malignant Pleural Mesothelioma	Phase 2	US	Biogen, Inc.	01 Mar 2006
Pleural Effusion	Phase 2	US	Biogen, Inc.	01 Mar 2006
Colorectal Cancer	Phase 2	US	Biogen, Inc.	01 May 2005
Glioblastoma	Phase 2	-	Biogen, Inc.	-
Glioblastoma	Phase 2	-	AmpliPhi Biosciences Corp.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NRF (WCN2015)	Not Applicable	Multiple Sclerosis	388	Interferon beta therapy	pcvrvnbcxh(vtnijiursf) = tuvztwyjws lnclhvsqgx (zasdxkyrkj, 0.9–1.6) View more	Positive	15 Oct 2015

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