Phase 2
Completed N=27
Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
Source: ClinicalTrials.gov NCT00664521 ↗Enrolled (actual)
27
Serious AEs
29.6%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 17; 9; 6; 2 Participants
Summary
The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
17; 9; 6; 2 | — |
| PRIMARY Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) |
0; 0 | — |
| PRIMARY Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 |
3.74; -6.29; 1.09; 4.89; 10.21; -8.54 | — |
| PRIMARY Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32 |
-17.98; 0.00; -33.68; 8.41 | — |
| PRIMARY Percent Change From Baseline in Anti-pneumococcus Titer at Week 32 |
-18.49; 0.00 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32 |
33.3; 22.2; 11.1; 11.1; 5.6; 0 | — |
| SECONDARY Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32 |
5.50; 5.81; 3.85; 4.25 | — |
| SECONDARY Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells |
-100.00; -100.00; -100.00; -99.69; -100.00; -100.00 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects
- Greater than and equal to (>=) 18 years of age at the time of Informed Consent
- Who have rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 12 months
- Subjects must have active disease defined by DAS28 >3.2
- Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab
- Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before study day 1 (SD1), during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and SD1
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Current neurological disease excluding migraine
- Inflammatory joint disease other than rheumatoid arthritis
- Any contraindication to rituximab as per national label
- Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen >25 mg/week
- Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer)
- Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1
- Active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before SD1
- Serum Immunoglobulin G (IgG) below 6 gram per liter (g/L)
- Known hypersensitivity to atacicept or to any of the components of the formulated atacicpet
- Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins
- Breastfeeding or pregnancy
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT00664521). 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.