Phase 2
Completed N=386
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00550446 ↗
Enrolled (actual)
386
Serious AEs
3.7%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 — 31.48; 45.10; 61.22; 72.13 percentage of participants
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.)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 |
31.48; 45.10; 61.22; 72.13; 71.93; 39.62 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
16.67; NA; 31.37; NA; 32.65; 50.82 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response |
1.85; NA; 7.84; NA; 8.16; 18.03 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
1.85; NA; 1.96; NA; 2.04; 3.28 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response |
1.85; NA; 0.00; NA; 0.00; 1.64 | — |
| SECONDARY Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve |
-99.17; -21.41; 36.11; 117.91; 16.24; -82.12 | — |
| SECONDARY Tender Joint Count (TJC) |
27.02; NA; 24.55; NA; 27.14; 25.70 | — |
| SECONDARY Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET |
-5.04; NA; -7.61; NA; -8.23; -10.28 | — |
| SECONDARY Swollen Joint Counts (SJC) |
16.70; NA; 15.90; NA; 17.35; 16.33 | — |
| SECONDARY Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 |
-4.83; NA; -3.08; NA; -4.85; -5.67 | — |
| SECONDARY Patient Assessment of Arthritis Pain |
59.74; NA; 61.25; NA; 64.14; 62.92 | — |
| SECONDARY Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET |
-5.98; NA; -16.00; NA; -16.33; -19.33 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain |
60.74; NA; 59.76; NA; 67.55; 62.41 | — |
| SECONDARY Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET |
-5.72; NA; -11.27; NA; -16.33; -21.48 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis |
62.13; NA; 62.10; NA; 65.85; 61.05 | — |
| SECONDARY 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 |
-9.83; NA; -14.24; NA; -14.93; -21.14 | — |
| SECONDARY C-Reactive Protein (CRP) |
21.39; NA; 16.22; NA; 24.51; 16.66 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET |
-5.59; NA; -4.59; NA; -15.32; -11.77 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) |
1.57; NA; 1.53; NA; 1.40; 1.49 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET |
-0.13; NA; -0.25; NA; -0.16; -0.27 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
5.51; NA; 5.37; NA; 5.58; 5.46 | — |
| SECONDARY 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 |
-0.55; NA; -0.77; NA; -0.95; -1.28 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) |
6.51; NA; 6.35; NA; 6.57; 6.46 | — |
| SECONDARY 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 |
-0.56; NA; -0.81; NA; -0.98; -1.32 | — |
| SECONDARY Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) |
3.9; NA; 2.0; NA; 4.3; 3.3 | — |
| SECONDARY Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) |
25.58; NA; 33.33; NA; 62.50; 71.11 | — |
| SECONDARY Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) |
1.89; NA; 4.00; NA; 4.17; 5.00 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) |
29.75; NA; 29.88; NA; 29.93; 30.30 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET |
3.11; NA; 4.90; NA; 6.64; 8.90 | — |
| SECONDARY Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score |
0.41; NA; 0.33; NA; 0.39; 0.41 | — |
| SECONDARY Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET |
0.15; NA; 0.14; NA; 0.21; 0.27 | — |
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
Data sourced from ClinicalTrials.gov (NCT00550446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.