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Long Term Open Label Continuation Study

NCT ID: NCT00195650

Last Updated: 2012-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

846 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.

Detailed Description

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Study DE020 was a multicenter, open-label continuation study for patients with rheumatoid arthritis who had participated in a prior Phase 1, 2, or 3 adalimumab study in the United States or Canada, had a favorable safety and efficacy profile when treated with adalimumab, and met the eligibility criteria for the continuation study. Participants received subcutaneous injections of adalimumab every other week (eow) or monthly based on the adalimumab regimen received in the prior study (i.e., participants who received monthly dosing in the prior study began the continuation study on monthly dosing; all other participants began adalimumab dosing at eow intervals). Participants who maintained an American College of Rheumatology 50% (ACR50) response for 2 consecutive visits could have their dosing interval lengthened to a monthly dosing schedule. Safety and efficacy data were collected over 520 weeks (10 years). Both safety and efficacy data were analyzed using all participants who received at least 1 dose of open-label adalimumab in the 10-year continuation study DE020 (the Full Analysis Set, n=846). Three patients who entered the continuation study but were never dosed were excluded from all analyses.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adalimumab

Open-label adalimumab 40 mg

Group Type EXPERIMENTAL

Adalimumab

Intervention Type BIOLOGICAL

Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)

Interventions

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Adalimumab

Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)

Intervention Type BIOLOGICAL

Other Intervention Names

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Humira, ABT-D2E7

Eligibility Criteria

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Inclusion Criteria

* Participant was in a prior D2E7 (adalimumab) study
* Participant was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.

Exclusion Criteria

* Participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant
* Participant had any ongoing chronic or active infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hartmut Kupper, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 538

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 4111

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 4113

Mobile, Alabama, United States

Site Status

Site Reference ID/Investigator# 408

Anchorage, Alaska, United States

Site Status

Site Reference ID/Investigator# 537

Tucson, Arizona, United States

Site Status

Site Reference ID/Investigator# 66822

Anaheim, California, United States

Site Status

Site Reference ID/Investigator# 557

La Jolla, California, United States

Site Status

Site Reference ID/Investigator# 387

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 555

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 552

Santa Barbara, California, United States

Site Status

Site Reference ID/Investigator# 66864

Santa Monica, California, United States

Site Status

Site Reference ID/Investigator# 535

Stanford, California, United States

Site Status

Site Reference ID/Investigator# 3412

Upland, California, United States

Site Status

Site Reference ID/Investigator# 451

Westlake Village, California, United States

Site Status

Site Reference ID/Investigator# 572

Colorado Springs, Colorado, United States

Site Status

Site Reference ID/Investigator# 4109

Denver, Colorado, United States

Site Status

Site Reference ID/Investigator# 541

Danbury, Connecticut, United States

Site Status

Site Reference ID/Investigator# 654

Milford, Connecticut, United States

Site Status

Site Reference ID/Investigator# 655

Wilmington, Delaware, United States

Site Status

Site Reference ID/Investigator# 455

Daytona Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 431

Fort Lauderdale, Florida, United States

Site Status

Site Reference ID/Investigator# 574

Fort Myers, Florida, United States

Site Status

Site Reference ID/Investigator# 66843

Gainesville, Florida, United States

Site Status

Site Reference ID/Investigator# 579

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 571

Palm Harbor, Florida, United States

Site Status

Site Reference ID/Investigator# 651

Sarasota, Florida, United States

Site Status

Site Reference ID/Investigator# 66863

St. Petersburg, Florida, United States

Site Status

Site Reference ID/Investigator# 542

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 415

Vero Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 652

Zephyrhills, Florida, United States

Site Status

Site Reference ID/Investigator# 449

Boise, Idaho, United States

Site Status

Site Reference ID/Investigator# 4110

Boise, Idaho, United States

Site Status

Site Reference ID/Investigator# 650

Coeur d'Alene, Idaho, United States

Site Status

Site Reference ID/Investigator# 578

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 4112

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 547

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 534

Metairie, Louisiana, United States

Site Status

Site Reference ID/Investigator# 544

Chevy Chase, Maryland, United States

Site Status

Site Reference ID/Investigator# 653

Boston, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 4114

Worcester, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 546

Petoskey, Michigan, United States

Site Status

Site Reference ID/Investigator# 577

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 549

Billings, Montana, United States

Site Status

Site Reference ID/Investigator# 561

Reno, Nevada, United States

Site Status

Site Reference ID/Investigator# 573

Dover, New Jersey, United States

Site Status

Site Reference ID/Investigator# 66842

Toms River, New Jersey, United States

Site Status

Site Reference ID/Investigator# 559

Voorhees Township, New Jersey, United States

Site Status

Site Reference ID/Investigator# 562

Albuquerque, New Mexico, United States

Site Status

Site Reference ID/Investigator# 66823

Brooklyn, New York, United States

Site Status

Site Reference ID/Investigator# 432

Lake Success, New York, United States

Site Status

Site Reference ID/Investigator# 657

New York, New York, United States

Site Status

Site Reference ID/Investigator# 647

New York, New York, United States

Site Status

Site Reference ID/Investigator# 545

Port Jefferson Station, New York, United States

Site Status

Site Reference ID/Investigator# 540

Syracuse, New York, United States

Site Status

Site Reference ID/Investigator# 646

Statesville, North Carolina, United States

Site Status

Site Reference ID/Investigator# 438

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 436

Dayton, Ohio, United States

Site Status

Site Reference ID/Investigator# 548

Bend, Oregon, United States

Site Status

Site Reference ID/Investigator# 553

Eugene, Oregon, United States

Site Status

Site Reference ID/Investigator# 532

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 570

Bethlehem, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 575

Ridley Park, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 585

Willow Grove, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 2435

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 536

Richmond, Virginia, United States

Site Status

Site Reference ID/Investigator# 649

Everett, Washington, United States

Site Status

Site Reference ID/Investigator# 66862

Everett, Washington, United States

Site Status

Site Reference ID/Investigator# 531

Kirkland, Washington, United States

Site Status

Site Reference ID/Investigator# 412

Olympia, Washington, United States

Site Status

Site Reference ID/Investigator# 658

Spokane, Washington, United States

Site Status

Site Reference ID/Investigator# 576

Vancouver, Washington, United States

Site Status

Site Reference ID/Investigator# 551

Yakima, Washington, United States

Site Status

Site Reference ID/Investigator# 656

Glendale, Wisconsin, United States

Site Status

Site Reference ID/Investigator# 539

Milwaukee, Wisconsin, United States

Site Status

Site Reference ID/Investigator# 513

Calgary, , Canada

Site Status

Site Reference ID/Investigator# 568

Charlottetown, , Canada

Site Status

Site Reference ID/Investigator# 565

Hamilton, , Canada

Site Status

Site Reference ID/Investigator# 564

Hamilton, , Canada

Site Status

Site Reference ID/Investigator# 569

Kitchener, , Canada

Site Status

Site Reference ID/Investigator# 3440

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 413

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 66805

North York, , Canada

Site Status

Site Reference ID/Investigator# 66807

North York, , Canada

Site Status

Site Reference ID/Investigator# 414

Ottawa, , Canada

Site Status

Site Reference ID/Investigator# 566

Pointe-Claire, , Canada

Site Status

Site Reference ID/Investigator# 2467

Sainte-Foy, Quebec, , Canada

Site Status

Site Reference ID/Investigator# 66804

Scarborough, , Canada

Site Status

Site Reference ID/Investigator# 563

St. John's, , Canada

Site Status

Site Reference ID/Investigator# 2466

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 567

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 3442

Vancouver, , Canada

Site Status

Site Reference ID/Investigator# 514

Winnipeg, , Canada

Site Status

Countries

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United States Canada

References

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Furst DE, Kavanaugh A, Florentinus S, Kupper H, Karunaratne M, Birbara CA. Final 10-year effectiveness and safety results from study DE020: adalimumab treatment in patients with rheumatoid arthritis and an inadequate response to standard therapy. Rheumatology (Oxford). 2015 Dec;54(12):2188-97. doi: 10.1093/rheumatology/kev249. Epub 2015 Jul 21.

Reference Type DERIVED
PMID: 26199453 (View on PubMed)

Other Identifiers

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DE020

Identifier Type: -

Identifier Source: org_study_id