Trial · NCT01557322
Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
NCT01557322, Completed, Pfizer; results first posted 2013-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Characterize Patients With Moderately Active Rheumatoid Arthritis (RA). Trials, record NCT01557322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01557322
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
- NCT number
- NCT01557322
- Status
- Completed
- Enrollment
- 1,754 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- etanercept, methotrexate (MTX)
- First posted
- 2012-03-19
- Last updated
- 2013-10-31
- Results first posted
- 2013-10-31
- Limitations and caveats
Since this study was a retrospective registry analysis of de-identified participants' data, only SAEs pre specified in analysis were reported with preferred terms and all other SAEs were reported under the preferred term Other Serious Event.
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With American College of Rheumatology (ACR) Criteria | Baseline | ACR criteria: 1) Morning stiffness: in and around joints, lasting at least (\>=) 1 hour; 2) Arthritis/deformity of \>=3 joint areas: presence of soft tissue swelling or fluid (not bony overgrowth alone), 14 possible areas are right/left proximal interphalangeal (PIP), metacarpophalangeal (MCP), wrist, elbow, knee, ankle, metatarsophalangeal (MTP) joints; 3) Arthritis of hand joints: \>=1 area swollen in wrist, MCP, PIP joint; 4) Symmetric arthritis: simultaneous involvement of same joint areas (as defined in 2) on both sides of body; 5): Rheumatoid nodules: subcutaneous nodules over bony prominences or extensor surfaces or in juxtaarticular regions; 6): Rheumatoid factor (RF): abnormal amounts of RF by any method for which result has been positive in \<5% of normal control participants; 7) Radiographic changes: typical of RA on posteroanterior hand and wrist radiographs, which must include erosions/unequivocal bony decalcification localized in or most marked adjacent to involved joints. |
| Primary | Number of Participants With Systemic Features | Baseline | Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified). |
| Primary | Number of Participants With Prior Joint Replacement or Surgery | Baseline | Participants who had prior total knee replacement, total hip replacement, total shoulder replacement, total elbow replacement, wrist/hand/ankle/foot surgery, and neck surgery are reported. |
| Primary | Number of Participants With Chest X-Ray Prior to New Therapy | Baseline | |
| Primary | Number of Participants With Comorbidities | Baseline | Comorbidities included: hypertension, moderate or severe heart failure, angina, stroke, epilepsy, asthma, chronic bronchitis/emphysema, peptic ulcer, tuberculosis, pre-existing or recent onset of central nervous system demyelinating disorders, chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis, active tuberculosis, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease, malignancy or history of malignancy, hyperthyroidism, depression and/or anxiety, recent substance abuse (drug or alcohol), human immunodeficiency virus (HIV) infection or active hepatitis B/C infection (including associated chronic active hepatitis). Participants suffering from any of the comorbidity are reported. |
| Primary | Body Mass Index (BMI) | Baseline | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2). |
| Primary | Blood Pressure (BP) | Baseline | BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). |
| Primary | Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 | Baseline, Month 60 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, acute phase reactants (erythrocyte sedimentation rate \[ESR, millimeters per hour\] or C-reactive protein \[CRP, milligram per liter\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<2.6: remission, DAS28 \<=3.2: low disease activity, DAS28 \>3.2 to \<=5.1: moderate disease activity, DAS28 \>5.1: progression. |
| Primary | Change From Baseline in Tender Joints Count (TJC) at Month 60 | Baseline, Month 60 | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. |
| Primary | Change From Baseline in Swollen Joints Count (SJC) at Month 60 | Baseline, Month 60 | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With American College of Rheumatology (ACR) Criteria | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Systemic Features | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively. | participants | NUMBER |
| PRIMARY | Number of Participants With Prior Joint Replacement or Surgery | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Chest X-Ray Prior to New Therapy | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Comorbidities | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively. | participants | NUMBER |
| PRIMARY | Body Mass Index (BMI) | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | kg/m^2 | MEAN |
| PRIMARY | Blood Pressure (BP) | Baseline | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively. | millimeter of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here n signifies participants evaluable at each time-point for each treatment arm, respectively. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Tender Joints Count (TJC) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | tender joints | MEAN |
| PRIMARY | Change From Baseline in Swollen Joints Count (SJC) at Month 60 | Baseline, Month 60 | Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively. | swollen joints | MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group300
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With American College of Rheumatology (ACR) Criteria | Etanercept | Morning Stiffness >1 Hour | 194 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | nbDMARDs | Morning Stiffness >1 Hour | 1316 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | Etanercept | Arthritis/Deformity of >=3 Joint Areas | 179 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | nbDMARDs | Arthritis/Deformity of >=3 Joint Areas | 1133 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | Etanercept | Arthritis/Deformity of Hand/Joint | 160 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | nbDMARDs | Arthritis/Deformity of Hand/Joint | 1123 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | Etanercept | Symmetry | 175 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | nbDMARDs | Symmetry | 978 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | Etanercept | Nodules | 91 | participants | |
| Number of Participants With American College of Rheumatology (ACR) Criteria | nbDMARDs | Nodules | 470 | participants |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etanercept | 211 | |
| Overall Study | STARTED | nbDMARDs | 1,543 | |
| Overall Study | COMPLETED | Etanercept | 211 | |
| Overall Study | COMPLETED | nbDMARDs | 1,543 | |
| Overall Study | NOT COMPLETED | Etanercept | 0 | |
| Overall Study | NOT COMPLETED | nbDMARDs | 0 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | General disorders | Etanercept | 3 | 211 | |
| serious | Pneumonia | General disorders | nbDMARDs | 63 | 1,543 | |
| serious | Septicaemia | General disorders | Etanercept | 0 | 211 | |
| serious | Septicaemia | General disorders | nbDMARDs | 5 | 1,543 | |
| serious | Bone/Joint Infection | General disorders | Etanercept | 2 | 211 | |
| serious | Bone/Joint Infection | General disorders | nbDMARDs | 5 | 1,543 | |
| serious | Other Infection | General disorders | Etanercept | 13 | 211 | |
| serious | Other Infection | General disorders | nbDMARDs | 40 | 1,543 | |
| serious | Congestive Heart Failure | General disorders | Etanercept | 1 | 211 | |
| serious | Congestive Heart Failure | General disorders | nbDMARDs | 7 | 1,543 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | ||
| Total, all-cause mortality | nbDMARDs | ||
| Total, other adverse events | Etanercept | 0 | 0 |
| Total, other adverse events | nbDMARDs | 0 | 0 |
| Total, serious adverse events | Etanercept | 77 | 211 |
| Total, serious adverse events | nbDMARDs | 534 | 1,543 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Etanercept vs nbDMARDs: Number of Participants With Chest X-Ray Prior to New Therapy | Trial comparisons |
| Etanercept vs nbDMARDs: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01557322
GET https://conductscience.org/api/trials/v1/NCT01557322/registered?page=2