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Active Rheumatoid ArthritisPhase 3NCT02586246

Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870

A Phase 3 study testing CDP870 in people with Active Rheumatoid Arthritis, run by Astellas Pharma Inc at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Active Rheumatoid Arthritis
What is being tested?
CDP870
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
15 sitesJapan
Study dates
Jan 2011to May 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Study site

    Aichi

  • Study site

    Fukuoka

  • Study site

    Gunma

  • Study site

    Hiroshima

  • Study site

    Hokkaido

  • Study site

    Hyōgo

  • Study site

    Kagawa

  • Study site

    Kagoshima

  • Study site

    Kanagawa

  • Study site

    Kumamoto

  • Study site

    Nagasaki

  • Study site

    Ōita

  • Study site

    Saitama

  • Study site

    Tokushima

  • Study site

    Tokyo

Other trials in Japan

About this study

Official title: Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Administered Concomitantly With or Without Methotrexate (MTX)

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.

Being tested
CDP870
Keywords
CDP870, Rheumatoid arthritis, Long-term
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDP870Drug

    Self-injection

Study groups in NCT02586246
Study groupRoleWhat they receive
CDP870 group from Study 275-08-002ExperimentalSubjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870
Receives: Drug: CDP870
CDP870 group from Study 275-08-004ExperimentalSubjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870
Receives: Drug: CDP870

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

    Measured: at Week 12

  3. Percentage of subjects who meet ACR20 criteria at Week 24

    Measured: at Week 24

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

    Measured: at Week 12

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

    Measured: at Week 24

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

    Measured: at Week 12

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

    Measured: at Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study startJan 2011
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586246
Sponsor's protocol ID
1226-CL-A003
Other IDs
275-10-001
Status last verified
Nov 2015
First submitted
23 Oct 2015
Last updated
16 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CDP870 in people with Active Rheumatoid Arthritis, run by Astellas Pharma Inc at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study (time frame: The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.

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