NCT00430495

Brief Summary

This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

February 17, 2016

Completed
Last Updated

February 17, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

January 30, 2007

Results QC Date

January 19, 2016

Last Update Submit

January 19, 2016

Conditions

Rheumatoid Arthritis

Keywords

ataciceptarthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26

    ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).

    Week 26

Secondary Outcomes (7)

  • Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26

    Week 26

  • Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26

    Week 26

  • Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26

    Week 26

  • Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26

    Week 26

  • Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26

    Week 26

  • +2 more secondary outcomes

Study Arms (4)

Atacicept 25 mg

EXPERIMENTAL
Drug: Atacicept

Atacicept 75 mg

EXPERIMENTAL
Drug: Atacicept

Atacicept 150 mg

EXPERIMENTAL
Drug: Atacicept

Placebo

PLACEBO COMPARATOR
Drug: Placebo matched to atacicept

Interventions

AtaciceptDRUG

Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.

Atacicept 25 mg
Placebo matched to ataciceptDRUG

Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic criteria with a disease history of at least one year
  • Male or female greater than or equal to (\>=)18-years of age at time of informed consent
  • Active RA as defined by:
  • \>=8 swollen joints (66-joint count),
  • \>=8 tender joints (68-joint count), and
  • C-reactive protein (CRP) \>=10 milligram per liter (mg/L) (central laboratory) and/or erythrocyte sedimentation rate (ESR) \>= to 28 millimeter per hour (mm/h)
  • Failure of at least one TNFa antagonist therapy (previously or at the time of screening) as specified in the protocol

You may not qualify if:

  • Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
  • Treatment with biologics aiming at B cell modulation such as rituximab or belimumab within 2 years before study Day 1
  • Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab within 3 months before study Day 1
  • Use of etanercept (Enbrel) within 28 days before study Day 1, or of infliximab (Remicade) or adalimumab (Humira) within 60 days before study Day 1
  • Participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study Day 1, whichever is longer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EMD Serono

Rockland, Massachusetts, 02370, United States

Location

Merck/Serono

Canada, Canada

Location

Related Publications (1)

  • Genovese MC, Kinnman N, de La Bourdonnaye G, Pena Rossi C, Tak PP. Atacicept in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor antagonist therapy: results of a phase II, randomized, placebo-controlled, dose-finding trial. Arthritis Rheum. 2011 Jul;63(7):1793-803. doi: 10.1002/art.30373.

    PMID: 21452293DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
service@merckgroup.com
+49-6151-72-5200

Study Officials

  • Medical Responsible

    EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 2, 2007

Study Start

December 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

February 17, 2016

Results First Posted

February 17, 2016

Record last verified: 2016-01

Locations

CA(1)US(1)