NCT00850343

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 17, 2014

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

4.2 years

First QC Date

February 23, 2009

Results QC Date

September 9, 2014

Last Update Submit

October 27, 2014

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisCertolizumab PegolCimzia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.

    From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.

Secondary Outcomes (5)

  • Percentage of Participants With American College of Rheumatology 20% (ACR20) Response

    Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)

  • Percentage of Participants With American College of Rheumatology 50% (ACR50) Response

    Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)

  • Percentage of Participants With American College of Rheumatology 70% (ACR70) Response

    Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)

  • Change From Baseline in Disease Activity Score (DAS) 28

    Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)

  • Change From Baseline in Modified Total Sharp Score (mTSS)

    Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100

Study Arms (2)

Certolizumab pegol 200 mg

EXPERIMENTAL

Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.

Drug: Certolizumab pegol

Certolizumab pegol 400 mg

EXPERIMENTAL

Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.

Drug: Certolizumab pegol

Interventions

Certolizumab pegolDRUG

Subcutaneous (SC) injection

Also known as: Cimzia, CDP870
Certolizumab pegol 200 mgCertolizumab pegol 400 mg

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who participated in Study 275-08-003 and meet all of the criteria described below.
  • Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.

You may not qualify if:

  • Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
  • Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
  • Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
  • Patients who required treatment for the same infection at two or more different times during Study 275-08-003
  • Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
  • Patients whom the investigator has decided to be inappropriate for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Director, Global Medical Sciences
Organization
Astellas Pharma Inc.
ClinicalTrials.Disclosure@astellas.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 3, 2014

Results First Posted

September 17, 2014

Record last verified: 2014-10

Locations

JP(8)