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Multicenter, Safety and Efficacy, Open-Label Extension Study Evaluating . . . The primary objective is to evaluate the effect of teprotumumab on the proptosis responder rate (i e , the percentage of subjects with a ≥ 2 mm reduction from Baseline in the study eye without deterioration [≥ 2 mm increase] of proptosis in the fellow eye) at Week 24the EOT Visit
A Trial to Investigate Teprotumumab Subcutaneous Administration . . . Official Title A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease
Teprotumumab Improves Outlook for Thyroid Eye Disease Teprotumumab, a monoclonal antibody, was approved by the FDA in 2020 for the treatment of thyroid eye disease (TED) Teprotumumab targets the insulin-like growth factor 1 receptor (IGF-1R)
A Trial to Investigate Teprotumumab Subcutaneous Administration . . . The main objective of the study is to evaluate the effect of teprotumumab subcutaneous administration versus placebo on the proptosis responder rate (ie, the percentage of participants with a ≥ 2-mm reduction from Baseline in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye) at Week 24
Treatment of Graves Orbitopathy (Thyroid Eye Disease) to Reduce . . . The overall objective is to investigate the efficacy, tolerability, and safety of teprotumumab (a fully human monoclonal antibody [mAb] inhibitor of the insulin-like growth factor-1 receptor [IGF-1R]) administered once every 3 weeks (q3W) for 21 weeks with a final assessment at Week 24, in comparison to placebo, in the treatment of participants
Teprotumumab Efficacy, Safety, and Durability in Longer-Duration . . . METHODS: OPTIC nonresponders or those who flared (≥2-mm increase in proptosis, ≥2-point increase in clinical activity score [CAS], or both) during follow-up were treated for the first time (previous placebo patients) or re-treated with teprotumumab in OPTIC-X with 8 infusions over 24 weeks
Teprotumumab Efficacy, Safety, and Durability in Longer-Duration . . . The Treatment of Graves’ Orbitopathy to Reduce Proptosis with Teprotumumab Infusions in an Open-Label Clinical Extension Study (OPTIC-X) is a teprotumumab treatment and re-treatment trial following the placebo-controlled teprotumumab Phase 3 Treatment of Graves’ Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab