An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

Not Applicable

• Conditions: -M059; M059

• Registration Number: PER-109-06
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Have provided written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
2. Have an age> 18 years.
3. Having presented a failure to at least 1 DMARD regimen.
4. During the last 6 months prior to the Screening visit, have received a diagnosis of RA based on the Revised Criteria of the American Society of Rheumatology.
5. Under the current treatment regimen, currently maintain a minimum disease activity level characterized by: a) ≥ 6 tender or painful joints to movement. b) ≥ 6 joints inflamed. c) C-reactive protein (CRP) (1 mg / dL (10 mg / L).
6. Complies with the Revised Criteria ACR 1991 for Global Functional Status in AR, Class I, II, or III.
7. The patient has complied with the washing periods if he has been treated with any of the treatments that require one.
8. If the patient is female, she must have met either: a) If she is not potentially fertile, the patient is amenorrheic for at least 2 years, or has had a hysterectomy and / or bilateral oophorectomy at least 8 weeks before screening. OR b) If the potentially fertile patient, must agree to use acceptable contraceptive methods.
9. If the patient is male, he or she must agree to use acceptable contraceptive methods.

Exclusion Criteria

1. A diagnosis of any other inflammatory arthritis or fibromyalgia.
2. A history of: a) Hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease severe, progressive, and uncontrolled within 6 months before the first dose. b) Associated significant cardiac disease. c) Chronic or serious or life-threatening infection within 6 months of the first dose. d) Untreated tuberculosis and / or positive tuberculin reaction to PPD without known vaccination with the Bacillus Calmette-Guerin (BCG) vaccine. e) Positive result to T-SPOT ™ .TB. f) Significant trauma or major surgery within 8 weeks of the first dose of study medication. f) Alcohol abuse with less than 6 months of sobriety; drug abuse within 3 years of the start of the study. g) Cancer, which has been in remission for <5 years.
3. Patients presenting with: a) Any condition that may affect the oral absorption of the drug. b) Any clinically significant skin lesion as described in the CTCAE Version 3.0. c) Body temperature of> 38 ° C (98.6 ° F). d) Infection with human immunodeficiency virus (HIV) or Hepatitis B or C. e) Any clinically significant active infection. f) Congestive heart failure Class III-IV. g) A confirmed average of the QTc interval in triplicate to the Selection> 450 ms. h) A clinically significant abnormal finding on the ECG.
4. Evidence of organic dysfunction or hematopoietic disorder.
5. Patients who require prohibited concomitant medications.
6. Pregnant or breast-feeding patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified