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Rheumatoid ArthritisPhase 4NCT00714493

RESTART C0168Z05 Rheumatoid Arthritis Study

A Phase 4 study testing Infliximab in people with Rheumatoid Arthritis, run by Centocor Ortho Biotech Services, L.L.C. at 76 sites in 10 countries.

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 purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Infliximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
76 sitesin 10 countries
Study dates
Jul 2008to Jun 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have rheumatoid arthritis
  • Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
  • Patients must have inadequate disease response to etanercept or adalimumab
  • Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

Who cannot join

  • Patients who have a history of latent or active TB
  • Have inflammatory disease other than rheumatoid arthritis
  • Have had a chronic or recurrent infectious disease.

Trial locations and contacts

76 sites in 10 countries.

76 sites in 10 countries

United States45 sites

  • Study site

    Albany, New York

  • Study site

    Allentown, Pennsylvania

  • Study site

    Amarillo, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Berkeley Heights, New Jersey

  • Study site

    Boca Raton, Florida

  • Study site

    Bridgeport, Connecticut

  • Study site

    Burke, Virginia

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Eagan, Minnesota

  • Study site

    Fort Worth, Texas

  • Study site

    Freehold, New Jersey

  • Study site

    Greenville, South Carolina

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Jackson, Tennessee

  • Study site

    Lewes, Delaware

  • Study site

    Lexington, Kentucky

  • Study site

    Mayfield, Ohio

  • Study site

    Mesquite, Texas

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Moline, Illinois

  • Study site

    Nashville, Tennessee

  • Study site

    Palm Harbor, Florida

  • Study site

    Paradise Valley, Arizona

  • Study site

    Reston, Virginia

  • Study site

    Saint Clair Shores, Michigan

  • Study site

    Santa Monica, California

  • Study site

    Seattle, Washington

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Syracuse, New York

  • Study site

    Tamarac, Florida

  • Study site

    Temple, Texas

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tyler, Texas

  • Study site

    Vero Beach, Florida

  • Study site

    Wexford, Pennsylvania

  • Study site

    Wheaton, Maryland

Other trials in United States

Israel7 sites

  • Study site

    Ashkelon

  • Study site

    Beer Yaakov

  • Study site

    Haifa

  • Study site

    Kfar Saba

  • Study site

    Ramat Gan

  • Study site

    Rehovot

  • Study site

    Tel Aviv

Other trials in Israel

Canada5 sites

  • Study site

    Hamilton Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Germany5 sites

  • Study site

    Frankfurt

  • Study site

    Holdenfelde

  • Study site

    Leipzig

  • Study site

    München

  • Study site

    Ratingen

Other trials in Germany

France4 sites

  • Study site

    Bordeaux

  • Study site

    Limoges

  • Study site

    Montivilliers

  • Study site

    Orléans

Other trials in France

Spain3 sites

  • Study site

    Madrid

  • Study site

    Oviedo

  • Study site

    Santiago de Compostela

Other trials in Spain

United Kingdom3 sites

  • Study site

    Leeds

  • Study site

    London

  • Study site

    Wigan

Other trials in United Kingdom

Austria2 sites

  • Study site

    Graz-Eggenberg

  • Study site

    Vienna

Other trials in Austria

Finland1 site

  • Study site

    Helsinki

Other trials in Finland

Netherlands1 site

  • Study site

    Alkmaar

Other trials in Netherlands

About this study

Official title: A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

Read the detailed description

This is a Phase 4, multi center, open-label, assessor blinded, switch study of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate response to their current treatment with etanercept or adalimumab. The last dose of etanercept must have been at least 1 week but not more than 2 weeks prior to the first infliximab study infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab study infusion. The study will be conducted for 30 weeks and will include 200 patients. All eligible patients will receive 3 mg/kg infliximab infusions (drug given into a vein) at weeks 0, 2, and 6 and every 8 weeks thereafter, if they achieve a European League Against Rheumatism (EULAR) response on their current dose of infliximab. Patients who do not achieve a EULAR response will increase their dose from 3mg/kg to 5 mg/kg at week 14. Patients who do not achieve a EULAR response at week 22 will increase from either 3 mg/kg to 5 mg/kg or from 5mg/kg to 7 mg/kg. The last study infusion will take place at week 22. The last study visit for effectiveness evaluations will take place at week 26. A week 30 follow-up visit will be performed for adverse events and tuberculosis evaluations, health economics assessments, and review of concomitant medications. All patients who end the study early will be required to complete all assessments. Patients will receive 3 mg/kg infliximab infusions at weeks 0, 2, and 6. If patients achieve European League Against Rheumatism (EULAR) response, they will remain on their current dose. Patients who do not demonstrate a EULAR response will increase their infliximab dose from 3 mg/kg to 5 mg/kg at week 14. At week 22, patients will also increase their infliximab dose from 3 mg/kg to 5mg/kg or from 5 mg/kg to 7mg/kg if they do not demonstrate a EULAR response.

Being tested
Infliximab
Keywords
rheumatoid arthritis, remicade, infliximab, Centocor, etanercept, enbrel, adalimumab, humira, restart, swollen joints, tender joints.
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • InfliximabBiological

    3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

Study groups in NCT00714493
Study groupRoleWhat they receive
001OtherInfliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Receives: Biological: Infliximab

What is being measured

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

  1. Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10

    Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.

    Measured: Week 10

Secondary outcomes (6)

  1. Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase

    Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase

    Measured: Week 26

  2. Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26

    Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26

    Measured: Week 26

  3. Change From Baseline in Physical Function (HAQ)

    Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.

    Measured: Week 10

  4. Change From Baseline in Physical Function (HAQ)

    Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.

    Measured: Week 26

  5. Percent of Patients Who Achieved ACR20 at Week 10

    Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.

    Measured: Week 10

  6. Percent of Patients Who Achieved ACR20 at Weeks 26.

    Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.

    Measured: Week 26

Timeline

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

  1. First posted14 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2010
  4. Study completionJun 2010

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00714493
Sponsor's protocol ID
CR013879
Other IDs
C0168Z05
Status last verified
Aug 2013
First submitted
10 Jul 2008
Last updated
12 Sep 2013
Data monitoring committee
No

Publications

  • Fleischmann R, Goldman JA, Leirisalo-Repo M, Zanetakis E, El-Kadi H, Kellner H, Bolce R, DeHoratius R, Wang J, Decktor D. Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study. Curr Med Res Opin. 2014 Nov;30(11):2139-49. doi: 10.1185/03007995.2014.942416. Epub 2014 Jul 30.

    PubMed 25050591

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Infliximab in people with Rheumatoid Arthritis, run by Centocor Ortho Biotech Services, L.L.C. at 76 sites in 10 countries.

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 4 inclusion and 3 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 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Israel, Canada, Germany, France and 5 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 (time frame: Week 10). 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 NCT00714493, which also lists 1 linked publication.

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 12 Sep 2013.

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