Phase 2
Completed N=312
GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
Source: ClinicalTrials.gov NCT01274182 ↗Enrolled (actual)
312
Serious AEs
12.5%
Results posted
Jan 2018
Primary outcomePrimary: AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA — 7627.44; 6896.97; 7536.89 day*mcg/mL
Summary
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA |
7627.44; 6896.97; 7536.89 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA |
361.53; 319.80; 335.88 | — |
| SECONDARY Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA |
1226.53; 1201.15; 1240.57 | — |
| SECONDARY Change From Baseline in DAS28(CRP) at Week 24 |
-2.07; -2.23; -1.99; -2.16 | — |
| SECONDARY Number of Patients With ACR20 (CRP) Response |
86; 55; 50; 56 | — |
| SECONDARY Summary of Disease Activity According to CDAI |
26; 20; 18; 18; 45; 32 | — |
| SECONDARY Summary of Disease Activity According to SDAI |
20; 15; 13; 15; 48; 34 | — |
| SECONDARY Participant Response as Assessed by EULAR Response Criteria |
0; 0; 0; 0; 101; 61 | — |
Eligibility Criteria
Inclusion Criteria
- Rheumatoid arthritis as defined by the 1987 ACR classification
- Severe active seropositive disease
- Inadequate response or intolerance to other DMARDs and anti-TNFs
- Treatment with Methotrexate
Exclusion Criteria
- Patients with systemic manifestations of rheumatoid arthritis
- Female patients nursing
- Women of childbearing potential unless using birth control
- Active infection
- Known immunodeficiency syndrome
- Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- History of cancer
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01274182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.