Phase 3 Completed N=956 Randomized Quadruple-blind Treatment

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

Arthritis, Rheumatoid

Source: ClinicalTrials.gov NCT01039688 ↗

Enrolled (actual)

956

Serious AEs

11.0%

Results posted

Apr 2018

Primary outcomePrimary: Modified Total Sharp Score (mTSS) at Month 6 — 20.50; 18.85; 17.54 score on a scale

◆ Published Evidence

Emerging

12citations · ~4 / year

Joint-level responses to tofacitinib and methotrexate: a post hoc analysis of data from ORAL Start.

Arthritis research & therapy · 2023 · Open access · Likely link

Full text ↗ PubMed 37773189 ↗ +4 more ↓

Summary

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Linked Publications (5)

Joint-level responses to tofacitinib and methotrexate: a post hoc analysis of data from ORAL Start.

Arthritis research & therapy · 2023 · 12 citations · Open access · Likely link

Full text ↗PubMed 37773189 ↗
Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib.

Arthritis research & therapy · 2024 · 6 citations · Open access · Likely link

Full text ↗PubMed 39192350 ↗
Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib.

The Journal of rheumatology · 2023 · 5 citations · Open access · Likely link

Full text ↗PubMed 37453736 ↗
Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials.

Rheumatology and therapy · 2024 · 2 citations · Open access · Likely link

Full text ↗PubMed 38958913 ↗
Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention.

Open access rheumatology : research and reviews · 2024 · 1 citation · Open access · Likely link

Full text ↗PubMed 38883150 ↗

Outcome Measures

Outcome	Result	p-value
PRIMARY Modified Total Sharp Score (mTSS) at Month 6	20.50; 18.85; 17.54	—
PRIMARY Change From Baseline at Month 6 in mTSS	0.20; 0.15; 0.65	0.0014 sig
PRIMARY Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6	25.41; 37.34; 12.09	<0.0001 sig
PRIMARY Absolute Blood Pressure (BP) Values (mmHg)	123.37; 124.30; 123.47; 77.64; 77.59; 78.02	—
PRIMARY Change From Baseline in BP Values (mmHg)	0.44; 0.32; -0.02; 0.11; 0.78; -1.91	—
SECONDARY mTSS Score at Baseline, Months 12 and 24	19.05; 17.89; 16.11; 19.23; 18.08; 17.32	—
SECONDARY Change From Baseline in mTSS Score at Months 12 and 24	0.37; 0.17; 1.20; 0.57; 0.28; 2.11	—
SECONDARY Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24	87.07; 89.25; 73.65; 82.42; 87.67; 69.01	—
SECONDARY Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24	91.67; 93.01; 81.44; 88.47; 90.88; 74.85	—
SECONDARY Erosion Scores	9.05; 9.06; 8.38; 9.18; 9.15; 8.78	—
SECONDARY JSN Scores	10.01; 8.82; 7.72; 10.09; 8.86; 8.17	—
SECONDARY Change From Baseline in Erosion Scores	0.14; 0.10; 0.35; 0.13; 0.12; 0.58	—
SECONDARY Change From Baseline in JSN Scores	0.06; 0.05; 0.29; 0.23; 0.05; 0.60	—
SECONDARY Percentage of Participants Achieving an ACR70 Response	5.22; 9.23; 0.55; 16.16; 23.02; 3.30	—
SECONDARY Percentage of Participants Achieving an ACR20 Response	49.32; 58.27; 21.20; 63.59; 71.57; 42.39	—
SECONDARY Percentage of Participants Achieving an ACR50 Response	17.98; 27.99; 3.80; 32.61; 40.10; 11.41	—
SECONDARY Tender Joints Count (TJC)	25.65; 25.12; 25.41; 15.75; 13.66; 20.07	—
SECONDARY Change From Baseline in TJC	-9.43; -11.40; -5.11; -12.95; -14.33; -8.63	—
SECONDARY Swollen Joints Count (SJC)	16.27; 15.58; 16.76; 9.90; 8.02; 12.56	—
SECONDARY Change From Baseline in SJC	-5.99; -7.75; -3.55; -8.95; -10.03; -5.98	—
SECONDARY Patient Assessment of Arthritis Pain	59.06; 61.37; 58.77; 36.62; 32.78; 46.34	—
SECONDARY Change From Baseline in Patient Assessment of Arthritis Pain	-22.98; -27.26; -13.43; -27.73; -29.71; -19.90	—
SECONDARY Physician Global Assessment of Arthritis	61.97; 60.50; 59.25; 36.70; 33.05; 45.52	—
SECONDARY Change From Baseline in Physician Global Assessment of Arthritis	-24.89; -28.32; -15.79; -33.92; -35.49; -24.17	—
SECONDARY Patient Global Assessment of Arthritis	60.20; 60.88; 57.71; 38.27; 32.63; 46.15	—
SECONDARY Change From Baseline in Patient Global Assessment of Arthritis	-22.22; -27.87; -14.12; -28.74; -31.54; -18.86	—
SECONDARY C-Reactive Protein	22.68; 20.25; 25.92; 6.62; 3.23; 17.37	—
SECONDARY Change From Baseline in CRP	-15.64; -18.84; -5.55; -16.02; -18.59; -6.83	—
SECONDARY Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP	5.56; 5.46; 5.62; 4.21; 3.77; 4.96	—
SECONDARY Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])	6.62; 6.54; 6.60; 5.18; 4.70; 5.84	—
SECONDARY Change From Baseline in DAS28-3(CRP)	-1.30; -1.71; -0.58; -1.85; -2.16; -1.02	—
SECONDARY Change From Baseline in DAS28-4(ESR)	-1.40; -1.83; -0.72; -2.03; -2.36; -1.17	—
SECONDARY Percentage of Participants With DAS28-3(CRP) ≤3.2	16.67; 33.16; 5.98; 35.42; 47.97; 14.13	—
SECONDARY Percentage of Participants With DAS28-4(ESR) ≤3.2	7.40; 14.09; 2.99; 18.42; 25.81; 4.71	—
SECONDARY Percentage of Participants With DAS28-3(CRP) <2.6	7.38; 14.14; 2.72; 20.44; 28.68; 5.43	—
SECONDARY Percentage of Participants With DAS28-4(ESR) <2.6	2.07; 5.69; 0.00; 9.06; 12.90; 2.35	—
SECONDARY Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)	71.86; 80.46; 37.50; 80.11; 85.79; 58.15	—
SECONDARY Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)	62.43; 74.25; 33.53; 74.27; 82.26; 50.00	—
SECONDARY Percentage of Participants With an ACR70 Response Sustained at Least 6 Months	28.42; 38.54; 13.98	—
SECONDARY Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits	8.6; 6.5; 7.5; 8.6; 11.1; 14.5	—
SECONDARY Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits	9.9; 9.8; 9.1; 10.7; 9.1; 8.1	—
SECONDARY Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits	10.7; 8.8; 5.9; 5.9; 7.8; 3.8	—
SECONDARY Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits	10.2; 10.6; 7.0; 8.6; 8.6; 7.0	—
SECONDARY Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits	6.2; 7.6; 4.3; 5.4; 5.3; 2.7	—
SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI)	1.54; 1.50; 1.52; 1.05; 0.89; 1.30	—
SECONDARY Change From Baseline in HAQ-DI Score	-0.48; -0.62; -0.23; -0.65; -0.77; -0.35	—
SECONDARY Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score	64.38; 73.91; 45.65; 69.13; 79.85; 61.41	—
SECONDARY Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score	54.79; 65.73; 32.61; 62.30; 73.21; 47.83	—
SECONDARY Percentage of Participants With at Least 0.5 Improvement in HAQ-DI	47.95; 55.75; 26.09; 55.46; 67.86; 39.67	—
SECONDARY Short Form 36 (SF-36) Mental Component Score	40.48; 40.73; 40.93; 44.90; 46.70; 43.98	—
SECONDARY SF-36 Physical Component Score	32.92; 33.20; 33.58; 33.81; 40.61; 35.40	—
SECONDARY Change From Baseline in SF-36 Mental Component Score	4.37; 6.14; 3.25; 5.39; 5.51; 3.41	—
SECONDARY Change From Baseline in SF-36 Physical Component Score	5.83; 7.54; 2.17; 8.04; 9.45; 4.23	—
SECONDARY SF-36 Domain Scores	41.87; 41.63; 41.77; 47.94; 48.99; 44.83	—
SECONDARY Change From Baseline in SF-36 Domain Scores	6.04; 7.27; 3.03; 7.36; 7.94; 3.68	—
SECONDARY Work Limitation Questionnaire (WLQ) Score	46.41; 47.79; 47.26; 51.18; 50.99; 50.15	—
SECONDARY Change From Baseline in WLQ Scores	-14.28; -16.87; -10.46; -16.99; -20.12; -15.78	—
SECONDARY WLQ Work Loss Index Score	11.00; 11.21; 10.55; 8.05; 7.60; 8.32	—
SECONDARY Change From Baseline in WLQ Work Loss Index Score	-2.82; -3.21; -2.03; -3.24; -4.23; -3.18	—
SECONDARY European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score	0.39; 0.42; 0.46; 0.67; 0.69; 0.63	—
SECONDARY Change From Baseline in EQ-5D Health State Profile Utility Score	0.26; 0.28; 0.21; 0.27; 0.30; 0.20	—
SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6	1.12; 1.13; 1.12; 1.95; 1.91; 1.91	—
SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24	1.45; 1.44; 1.41; 1.95; 1.98; 1.96	—
SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6	4.81; 4.37; 4.82; 1.55; 1.46; 1.56	—
SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24	2.19; 2.19; 2.22; 0.77; 0.74; 0.89	—
SECONDARY Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6	19.07; 23.76; 15.45; 30.60; 41.67; 99.94	—
SECONDARY Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24	10.43; 9.25; 9.00; 54.00; 20.00; 118.05	—
SECONDARY Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6	1.50; 2.20; 1.00; 1.00; 0.83; 1.33	—
SECONDARY Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24	2.00; 25.00; 0.00; 0.00; 8.38; 7.99	—
SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU	4.94; 4.71; 4.57; 3.59; 3.25; 3.57	—
SECONDARY Change From Baseline in Work Productivity and HCRU at Months 3 and 6	0.24; 0.18; 0.18; 0.01; 0.04; 0.06	—
SECONDARY Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24	0.34; 0.31; 0.26; 0.00; 0.05; 0.04	—
SECONDARY Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6	-1.83; -1.12; -1.52; -0.55; -0.50; -0.48	—
SECONDARY Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24	-2.57; -2.32; -3.17; -0.72; -0.68; -0.72	—
SECONDARY Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6	-10.00; 0.00; -45.92; -12.36; -65.50; -0.31	—
SECONDARY Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24	-2.00; 3.50; -27.07; -5.00; -75.00; -0.46	—
SECONDARY Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6	-1.00; 0.00; 0.23; 0.34; 0.80; -1.00	—
SECONDARY Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24	0.34; -0.21; 0.75; -1.60; 0.00; 0.29	—
SECONDARY Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU	-1.40; -1.45; -0.81; -2.11; -2.44; -1.22	—
SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3	42.65; 42.82; 42.84; 40.66; 41.43; 41.13	—
SECONDARY Percentage of Participants With Optimal Sleep Assessed Using MOS-SS	55.31; 55.22; 51.09; 57.06; 55.41; 48.88	—
SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24	30.73; 30.05; 32.71; 30.59; 29.81; 32.17	—
SECONDARY Change From Baseline in MOS-SS at Months 1, 2, and 3	-8.95; -9.14; -4.72; -7.85; -8.12; -3.98	—
SECONDARY Change From Baseline in MOS-SS at Months 6, 12, 18, and 24	-11.62; -12.24; -9.77; -10.13; -11.12; -8.64	—
SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale	28.47; 29.06; 28.55; 34.39; 36.03; 31.70	—
SECONDARY Change From Baseline in FACIT-Fatigue Scale	5.79; 7.14; 3.15; 7.44; 7.86; 4.22	—
SECONDARY Change From Baseline in Heart Rate	-1.64; -1.83; -0.73; -1.37; -1.02; -2.19	—
SECONDARY Change From Baseline in Temperature	-0.07; -0.05; -0.05; -0.07; -0.03; -0.04	—

Eligibility Criteria

Inclusion Criteria

Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion Criteria

Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
History of any other rheumatic autoimmune 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
No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01039688) and the linked publication. 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.