This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel, dummy treatment (placebo)- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD, designed to assess the how well it works and safety of GenSci120 injection in this patient population. The study consists of a screening period (≤ 4 weeks), a compared with a dummy treatment treatment period (14 weeks), an extension treatment period (14 weeks), and a follow-up period (10 weeks), with a total of 17 scheduled visits.
Official registry: https://clinicaltrials.gov/study/NCT07423533 · Changchun GeneScience Pharmaceutical Co., Ltd. · enrollment listed as 450
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are GenSci120 150 mg, GenSci120 600 mg, or GenSci120 1000 mg. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel, dummy treatment (placebo)- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD, designed to assess the how well it works and safety of GenSci120 injection in this patient population.
They plan to enroll about 450 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Disease-modifying Antirheumatic Drug
Interventions: GenSci120 150 mg, GenSci120 600 mg, GenSci120 1000 mg, adalimumab injection 40 mg, Placebo
Primary outcome (registry wording): Proportion of participants achieving the American College of Rheumatology 20% improvement criteria (ACR20) for disease activity assessment in RA from baseline after 14 weeks of administration
Wei WANG
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
This study wants to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters.
NCT01776398 · Official ClinicalTrials.gov record · Weill Medical College of Cornell University
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure.
NCT03414502 · Official ClinicalTrials.gov record · University of Nebraska
In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites.
NCT04748809 · Official ClinicalTrials.gov record · University of California, San Diego
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary