NCT02586246

Brief Summary

The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection administered for 24 weeks or longer in subjects who are participating in the long-term treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly with or without Methotrexate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

15 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

January 1, 2011

Completed
2.3 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
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

October 23, 2015

Last Update Submit

November 13, 2015

Conditions

Active Rheumatoid Arthritis

Keywords

CDP870Rheumatoid arthritisLong-term

Outcome Measures

Primary Outcomes (7)

  • Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study

    The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks.

  • Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12

    at Week 12

  • Percentage of subjects who meet ACR20 criteria at Week 24

    at Week 24

  • Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12

    at Week 12

  • Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24

    at Week 24

  • Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12

    at Week 12

  • Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24

    at Week 24

Study Arms (2)

CDP870 group from Study 275-08-002

EXPERIMENTAL

Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870

Drug: CDP870

CDP870 group from Study 275-08-004

EXPERIMENTAL

Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870

Drug: CDP870

Interventions

CDP870DRUG

Self-injection

CDP870 group from Study 275-08-002CDP870 group from Study 275-08-004

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have completed the treatment in the parent clinical studies (NCT00851318 and NCT00850343) up to 52 weeks
  • Subjects who are willing to undertake self-injection and provide a written consent

You may not qualify if:

  • Patients with serious adverse events
  • Patients who are judged by the investigator/subinvestigator to be ineligible to participation in the study for reasons such as uncooperative attitude or nonadherence to study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gunma, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Hyōgo, Japan

Location

Unknown Facility

Kagawa, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Ōita, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Tokushima, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Links

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

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 26, 2015

Study Start

January 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

JP(15)