A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

NCT00303563 | Completed Phase 2

• 1 other identifier: PA18604
• Study Type: interventional
• Target: 204
• Locations: 12 countries
• Sites: 61

Brief Summary

This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with ACR 20 response

  Week 12

Secondary Outcomes (2)

• Percentage of patients with ACR 50/70 response.

  Week 12

• Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.

  Throughout study

Study Arms (4)

1

EXPERIMENTAL

Drug: P38 Inhibitor (4)

2

EXPERIMENTAL

Drug: P38 Inhibitor (4)

3

EXPERIMENTAL

Drug: P38 Inhibitor (4)

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

P38 Inhibitor (4) DRUG

50mg po qd

1

Placebo DRUG

po qd

4

Eligibility Criteria

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

You may qualify if:

• adult patients \>18 years of age, with active RA;
• receiving treatment for RA on an outpatient basis;
• females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.

You may not qualify if:

• major surgery within 8 weeks prior to screening;
• rheumatic autoimmune disease or inflammatory joint disease other than RA;
• treatment with methotrexate within 8 weeks of baseline;
• concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (61)

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Anniston, Alabama, 36207, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85712, United States

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Escondido, California, 92025, United States

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Loma Linda, California, 92357, United States

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Stamford, Connecticut, 06905, United States

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Morton Grove, Illinois, 60053, United States

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South Bend, Indiana, 46601, United States

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Wichita, Kansas, 67207, United States

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Louisville, Kentucky, 40292, United States

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New Orleans, Louisiana, 70115, United States

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Belmont, North Carolina, 28012, United States

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Bend, Oregon, 97701, United States

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Danville, Pennsylvania, 17822, United States

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Lancaster, Pennsylvania, 17604, United States

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Charleston, South Carolina, 29407, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38104, United States

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Nashville, Tennessee, 37203, United States

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Amarillo, Texas, 79106, United States

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Dallas, Texas, 75231, United States

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Edmonton, Alberta, T5H 3V9, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Ottawa, Ontario, K2G 6E2, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Rijeka, 51000, Croatia

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Split, 21000, Croatia

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České Budějovice, 370 01, Czechia

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Prague, 128 50, Czechia

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Terezín, 411 55, Czechia

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Zlín, 760 01, Czechia

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Brest, 29609, France

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Corbeil-Essonnes, 91106, France

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Montpellier, 34295, France

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Paris, 75679, France

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Rouen, 76031, France

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Brescia, 25123, Italy

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Genova, 16132, Italy

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Pavia, 27100, Italy

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Roma, 00161, Italy

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Guadalajara, 44340, Mexico

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Guadalajara, 44620, Mexico

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Miexico City, 06700, Mexico

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Brasov, 500366, Romania

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Bucharest, 020125, Romania

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Belgrade, 11000, Serbia

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Bloemfontein, 9301, South Africa

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Johannesburg, 1619, South Africa

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Pretoria, 0002, South Africa

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A Coruña, 15006, Spain

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Barcelona, 08035, Spain

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Granada, 18014, Spain

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Jerez de la Frontera, 11407, Spain

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Madrid, 28040, Spain

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Oviedo, 33006, Spain

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Palma de Mallorca, 07007, Spain

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Seville, 41013, Spain

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Kaohsiung City, 00833, Taiwan

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Taoyuan District, 333, Taiwan

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Tapei, 114, Taiwan

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 17, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

TW (3); ES (8); FR (5); RO (2); CA (4); US (22); CR (2); IT (4); ME (3); CZ (4); SE (1); ZA (3)