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Phase 3 Completed N=717 Randomized Quadruple-blind Treatment

A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT00853385 ↗
Enrolled (actual)
717
Serious AEs
3.8%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 — 51.53; 52.55; 28.30; 47.24 percentage of participants — p=<0.0001

Summary

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
51.53; 52.55; 28.30; 47.24 <0.0001 sig
PRIMARY
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
1.50; 1.53; 1.42; 1.50; -0.49; -0.59 <0.0001 sig
PRIMARY
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
6.21; 12.50; 1.09; 6.74 <0.0001 sig
SECONDARY
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
41.24; 45.92; 16.04; 37.88; 60.71; 58.67
SECONDARY
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
49.49; 50.51; 30.36; 36.00; 47.24; 49.49
SECONDARY
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
14.95; 16.33; 4.72; 12.12; 34.18; 27.55
SECONDARY
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
35.71; 37.24; 17.86; 26.00; 29.15; 36.73
SECONDARY
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
2.58; 4.08; 0.94; 3.03; 12.24; 14.80
SECONDARY
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
18.37; 21.94; 8.93; 10.00; 11.06; 22.96
SECONDARY
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
5.43; 5.43; 5.44; 5.33; 4.26; 4.21
SECONDARY
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
3.13; 3.20; 3.11; 3.03; 3.46; 3.05
SECONDARY
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
6.56; 6.48; 6.45; 6.36; 5.23; 5.14
SECONDARY
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
4.00; 4.08; 3.99; 3.93; 4.20; 3.85
SECONDARY
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
SECONDARY
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
SECONDARY
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
1.15; 1.11; 1.32; 1.12; 1.00; 0.94
SECONDARY
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
0.86; 0.85; 0.89; 0.90; 0.97; 0.83
SECONDARY
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
59.29; 59.01; 55.20; 56.46; 39.71; 36.77
SECONDARY
Patient Assessment of Arthritis Pain at Month 9 and 12
27.04; 27.99; 31.31; 24.93; 32.70; 26.99
SECONDARY
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
59.86; 56.55; 54.46; 57.22; 41.85; 36.61
SECONDARY
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
28.39; 29.47; 31.78; 30.00; 34.38; 26.86
SECONDARY
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
59.92; 59.56; 60.28; 58.64; 38.90; 36.16
SECONDARY
Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
19.93; 21.92; 25.82; 23.78; 25.45; 18.67
SECONDARY
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
32.02; 31.06; 32.23; 31.74; 34.00; 33.54
SECONDARY
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
39.77; 38.74; 38.94; 38.59; 38.75; 41.66
SECONDARY
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
28.18; 28.56; 30.49; 27.95; 32.54; 33.95
SECONDARY
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
35.76; 37.53; 36.71; 35.71; 34.30
SECONDARY
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
42.13; 40.20; 39.14; 40.90; 43.24; 42.27
SECONDARY
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
34.62; 30.64; 34.69; 34.68; 35.72; 34.86
SECONDARY
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
94; 94; 49; 88; 93; 107
SECONDARY
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
80; 84; 28; 19; 75
SECONDARY
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
0.43; 0.43; 0.50; 0.45; 0.61; 0.60
SECONDARY
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
0.69; 0.69; 0.68; 0.66; 0.66
SECONDARY
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
41.46; 42.09; 37.65; 46.43; 49.99; 52.14
SECONDARY
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
25.59; 20.77; 32.69; 28.75; 26.57; 54.35
SECONDARY
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
1.16; 1.13; 1.15; 1.15; 1.95; 1.93
SECONDARY
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
1.31; 1.27; 1.24; 1.24; 1.23; 1.98
SECONDARY
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
4.26; 4.06; 4.50; 3.87; 1.33; 3.00
SECONDARY
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
2.73; 2.80; 3.92; 3.50; 2.94; 10.67
SECONDARY
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
13.64; 10.83; 13.43; 12.82; 19.33; NA
SECONDARY
Number of Days as Assessed Using RA-HCRU at Month 12
8.00; 5.60; 15.00; 1.00; 15.33; 24.50
SECONDARY
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
3.00; 1.50; 2.00; 1.00; 7.76; 7.54
SECONDARY
Number of Hours Per Day as Assessed RA-HCRU at Month 12
NA; NA; NA; NA; 1.00; 7.52
SECONDARY
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
4.16; 4.16; 4.08; 4.19; 2.68; 2.81
SECONDARY
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
2.18; 1.92; 2.69; 2.23; 1.93

Eligibility Criteria

Inclusion Criteria

  • The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
  • The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria

  • Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L
  • History of any other autoimmune rheumatic disease other than Sjogren's syndrome
  • No malignancy or history of malignancy.
  • History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
  • Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
  • Patients who have previously received adalimumab therapy for any reason.
  • Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
  • Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00853385). 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.

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