Clinical Trials/NCT00550446

NCT00550446

Completed

Phase 2

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Pfizer1 site in 1 country386 target enrollmentSeptember 2007

ConditionsArthritis, Rheumatoid

InterventionsAdalimumab CP-690-550 CP-690,550 Placebo

DrugsAdalimumab CP-690-550 CP-690,550 Placebo

Overview

Phase: Phase 2
Intervention: Adalimumab
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer
Enrollment: 386
Locations: 1
Primary Endpoint: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

January 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have active rheumatoid arthritis
•Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
•Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion Criteria

•Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
•Subjects who previously received adalimumab (Humira®) therapy for any reason.
•Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Arms & Interventions

1

Intervention: Adalimumab

2

Intervention: CP-690-550

3

Intervention: CP-690-550

4

Intervention: CP-690-550

5

Intervention: CP-690,550

6

Intervention: CP-690,550

7

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

Time Frame: Week 12

ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Secondary Outcomes

Patient Global Assessment (PtGA) of Arthritis Pain(Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response(Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET))
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 2, 4, 6, 8, 10, 12)
Tender Joint Count (TJC)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Swollen Joint Counts (SJC)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Patient Assessment of Arthritis Pain(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Physician Global Assessment (PGA) of Arthritis(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
C-Reactive Protein (CRP)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)(Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)(Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)(Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
36-Item Short-Form Health Survey (SF-36)(Baseline, Week 12, 24/ ET)
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET(Baseline, Week 12, 24/ ET)
Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score(Baseline, Week 12, 24/ ET)
Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET(Baseline, Week 12, 24/ ET)