Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

NCT00959036 | Completed Phase 1 DMC

• 2 other identifiers: 3242K1-2000B2271003
• Study Type: interventional
• Target: 252
• Locations: 9 countries
• Sites: 67

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.

Conditions

Active Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology (ACR) 20 response at week 16

  6 months

Secondary Outcomes (1)

• Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments

  6 months

Study Arms (6)

Treatment Group 1

EXPERIMENTAL

ATN-103 10 mg every 4 weeks until week 12

Drug: ATN-103; Drug: Methotrexate

Treatment Group 2

EXPERIMENTAL

ATN-103 10 mg every 8 weeks until week 12

Drug: ATN-103; Drug: Methotrexate

Treatment Group 3

EXPERIMENTAL

ATN-103 30 mg every 4 weeks until week 12

Drug: ATN-103; Drug: Methotrexate

Treatment Group 4

EXPERIMENTAL

ATN-103 80 mg every 4 weeks until week 12

Drug: ATN-103; Drug: Methotrexate

Treatment Group 5

EXPERIMENTAL

ATN-103 80 mg every 8 weeks until week 12

Drug: ATN-103; Drug: Methotrexate

Treatment Group 6

PLACEBO COMPARATOR

Placebo every 4 weeks

Drug: Placebo; Drug: Methotrexate

Interventions

ATN-103 DRUG

10 mg every 4 weeks until week 12

Treatment Group 1

Placebo DRUG

Placebo every 4 weeks

Treatment Group 6

Methotrexate DRUG

Treatment Group 1; Treatment Group 2; Treatment Group 3; Treatment Group 4; Treatment Group 5; Treatment Group 6

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).

You may not qualify if:

• Any significant health problem other than rheumatoid arthritis
• Any clinically significant laboratory abnormalities
• Any prior use of B cell-depleting therapy

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (67)

Investigational Site

Birmingham, Alabama, 35209, United States

Location

Investigational Site

Huntsville, Alabama, 35801, United States

Location

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Peoria, Arizona, 85381, United States

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Scottsdale, Arizona, 85258, United States

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Riverside, California, 92501, United States

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Upland, California, 91786, United States

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Bridgeport, Connecticut, 06606, United States

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Newark, Delaware, 19713, United States

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Lake Mary, Florida, 32746, United States

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Ocala, Florida, 34474, United States

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Orlando, Florida, 32804, United States

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Port Orange, Florida, 32127, United States

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Vero Beach, Florida, 32960, United States

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Coeur d'Alene, Idaho, 83814, United States

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Frederick, Maryland, 21702, United States

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West Yarmouth, Massachusetts, 12672, United States

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Lansing, Michigan, 48910, United States

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Freehold, New Jersey, 07728, United States

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Albuquerque, New Mexico, 87108, United States

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Mineola, New York, 11501, United States

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Charlotte, North Carolina, 28210, United States

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Hickory, North Carolina, 28601, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27157, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73139, United States

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Tulsa, Oklahoma, 74104, United States

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Lake Oswego, Oregon, 97035, United States

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Allentown, Pennsylvania, 18103, United States

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Columbia, South Carolina, 29204, United States

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Myrtle Beach, South Carolina, 29572, United States

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Nashville, Tennessee, 37205, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77004, United States

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San Antonio, Texas, 78217, United States

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Tacoma, Washington, 98405, United States

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Brussels, Belgium, 1200, Belgium

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Leuven, 3000, Belgium

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Winnipeg, Manitoba, R3A 1M3, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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St. Catharines, Ontario, L2N 7E4, Canada

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Toronto, Ontario, M9L 3A2, Canada

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Québec, Quebec, G1W 4R4, Canada

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Vogelsang, Gommern, 39245, Germany

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Budapest, 1027, Hungary

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Debrecen, 4012, Hungary

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Kemerovo, 650061, Russia

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Moscow, 113811, Russia

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Moscow, 119049, Russia

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Novosibirsk, 630047, Russia

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Novosibirsk, 630091, Russia

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Orenburg, 460000, Russia

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Petrozavodsk, 185019, Russia

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Ryazan, 390026, Russia

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Vladimir, 600023, Russia

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Yaroslavl, 150003, Russia

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Yaroslavl, 150062, Russia

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Belgrade, Serbia, 11000, Serbia

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Niška Banja, 18205, Serbia

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Berea, KwaZulu-Natal, 4001, South Africa

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Cape Town, 7405, South Africa

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Cape Town, 7500, South Africa

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Pretoria, 0181, South Africa

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Zurich, Canton of Zurich, 8091, Switzerland

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Chur, 7000, Switzerland

Location

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Josefin-Beate Holz, MD

  Ablynx, a Sanofi company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

DE (1); CA (6); CH (2); BE (2); ZA (4); RU (11); US (37); HU (2); SE (2)