Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00664521
• Date of registration: 21/04/2008
• Prospective Registration: No
• Primary sponsor: Merck KGaA
• Public title: Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III) August III
• Scientific title: A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.
• Date of first enrolment: March 2008
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00664521
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Finland, France, Netherlands, Sweden, United Kingdom

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Atacicept

Biological: Rituximab

Drug: Placebo matched to atacicept

Primary Outcome(s)

Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32 [Time Frame: Baseline, Week 32]

Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L) [Time Frame: Week 64]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 64]

Percent Change From Baseline in Anti-pneumococcus Titer at Week 32 [Time Frame: Baseline, Week 32]

Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32 [Time Frame: Baseline, Week 32]

Secondary Outcome(s)

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 [Time Frame: Week 32]

Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32 [Time Frame: Baseline, Week 32]

Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells [Time Frame: Baseline, Week 3, 7, 12, 16, 26 and 32]

Secondary ID(s)

28155

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/12/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00664521