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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00664521
First received: April 21, 2008
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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 receiving re-treatment with rituximab.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Rituximab
Biological: Atacicept / placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Nature, incidence and severity of adverse events (AEs) [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who develop IgG <3 g/L [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes / abnormalities in vital signs/ routine safety lab parameters [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes over time in vaccine immunization status [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ACR and DAS28 composite scores at week 26 [ Time Frame: Every 2 - 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: March 2008
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Rituximab
Rituximab 1000 mg IV infusion, 2nd 1000 mg IV infusion given 2 weeks later, followed 28 days later by atacicept/placebo 150 mg/mL SC once weekly for 25 weeks
Experimental: 2 Biological: Atacicept / placebo
Atacicept/placebo 150 mg/mL SC once weekly for 25 weeks, given in combination with rituximab 1000 mg IV infusion on study day 10, 2nd 1000 mg IV infusion given 2 weeks later

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects
  • >18 years of age at the time of Informed Consent
  • who have rheumatoid arthritis (satisfying American College of Rheumatology criteria)
  • a disease history of at least 12 months.
  • Subjects must have active disease defined by

    • >8 swollen joints (out of 66)
    • >8 tender joints (out of 68)
    • CRP >6 mg/L
    • ESR >28 mm/h.
  • 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 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.

Exclusion Criteria:

  • Neurological disease
  • 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 IgG below 6 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664521

Locations
France
Research Site
Nice, France
Research Site
Paris, France
Research Site
Strasbourg, France
Netherlands
Research Site
Amsterdam, Netherlands
Sweden
Research Site
Malmö, Sweden
Research Site
Stockholm, Sweden
United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
Norwich, United Kingdom
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00664521     History of Changes
Other Study ID Numbers: 28155
Study First Received: April 21, 2008
Last Updated: April 4, 2012
Health Authority: Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014