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5 Diseases |  |
0 Trials |
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0 Trials |  |
92 News |  |
- | M923 (adalimumab biosimilar) / J&J
Clinical, PK/PD data, Journal: Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects. (Pubmed Central) - Nov 7, 2018
The proportion of subjects with a confirmed antidrug antibody (ADA) response was similar across study arms. This study demonstrated bioequivalent PK among M923, US Humira, and EU Humira and demonstrated that the PK parameters were consistent with similar safety and tolerability profile and ADA response rates.
- || M923 (adalimumab biosimilar) / J&J
Enrollment change: Usability of an AI for M923 in Subjects With Moderate to Severe RA (clinicaltrials.gov) - May 1, 2018
P3, N=33, Completed, Sponsor: Momenta Pharmaceuticals, Inc.
This study demonstrated bioequivalent PK among M923, US Humira, and EU Humira and demonstrated that the PK parameters were consistent with similar safety and tolerability profile and ADA response rates. N=51 --> 33
- ||||| M923 (adalimumab biosimilar) / J&J
Enrollment change: Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis (clinicaltrials.gov) - Apr 4, 2018
P3, N=572, Completed, Sponsor: Momenta Pharmaceuticals, Inc.
N=51 --> 33 N=827 --> 572
- ||||||| M923 (adalimumab biosimilar) / J&J
Trial completion, P3 data: Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis (clinicaltrials.gov) - Jul 13, 2017
P3, N=827, Completed, Sponsor: Momenta Pharmaceuticals, Inc.
N=827 --> 572 Active, not recruiting --> Completed
- ||||||| M923 (adalimumab biosimilar) / J&J
Trial completion: Usability of an AI for M923 in Subjects With Moderate to Severe RA (clinicaltrials.gov) - Apr 21, 2017
P3, N=51, Completed, Sponsor: Momenta Pharmaceuticals, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| M923 (adalimumab biosimilar) / J&J
Trial primary completion date: Usability of an AI for M923 in Subjects With Moderate to Severe RA (clinicaltrials.gov) - Jan 10, 2017
P3, N=51, Active, not recruiting, Sponsor: Baxalta US Inc.
Active, not recruiting --> Completed Trial primary completion date: Dec 2016 --> Mar 2017
- ||||| M923 (adalimumab biosimilar) / J&J
Enrollment closed, Enrollment change: Usability of an AI for M923 in Subjects With Moderate to Severe RA (clinicaltrials.gov) - Aug 19, 2016
P3, N=51, Active, not recruiting, Sponsor: Baxalta US Inc.
Trial primary completion date: Dec 2016 --> Mar 2017 Recruiting --> Active, not recruiting | N=32 --> 51
- ||| M923 (adalimumab biosimilar) / J&J
Trial completion, Enrollment change: Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects (clinicaltrials.gov) - Aug 3, 2016
P1, N=603, Completed, Sponsor: Baxalta US Inc.
Recruiting --> Active, not recruiting | N=32 --> 51 Active, not recruiting --> Completed | N=156 --> 603
- || M923 (adalimumab biosimilar) / J&J
Enrollment closed: Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects (clinicaltrials.gov) - May 13, 2016
P1, N=156, Active, not recruiting, Sponsor: Baxalta US Inc.
Active, not recruiting --> Completed | N=156 --> 603 Recruiting --> Active, not recruiting
- | M923 (adalimumab biosimilar) / J&J
Enrollment open: Usability of an AI for M923 in Subjects With Moderate to Severe RA (clinicaltrials.gov) - Apr 28, 2016
P3, N=32, Recruiting, Sponsor: Baxalta US Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||||| M923 (adalimumab biosimilar) / J&J
Enrollment closed, P3 data, Enrollment change: Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis (clinicaltrials.gov) - Apr 12, 2016
P3, N=827, Active, not recruiting, Sponsor: Baxalta US Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=516 --> 827
- ||| M923 (adalimumab biosimilar) / J&J
New P3 trial: Usability of an AI for M923 in Subjects With Moderate to Severe RA (clinicaltrials.gov) - Mar 29, 2016
P3, N=32, Not yet recruiting, Sponsor: Baxalta US Inc.
- ||| M923 (adalimumab biosimilar) / J&J
Enrollment open: Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects (clinicaltrials.gov) - Mar 5, 2016
P1, N=156, Recruiting, Sponsor: Baxalta US Inc.
Recruiting --> Active, not recruiting | N=516 --> 827 Not yet recruiting --> Recruiting
- ||| M923 (adalimumab biosimilar) / J&J
New P1 trial: Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects (clinicaltrials.gov) - Feb 5, 2016
P1, N=156, Not yet recruiting, Sponsor: Baxalta US Inc.
- |||||||||| M923 (adalimumab biosimilar) / J&J
New P3 trial, P3 data: Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis (clinicaltrials.gov) - Oct 23, 2015
P3, N=516, Recruiting, Sponsor: Baxalta US Inc.