Trial Outcomes & Findings for Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study (NCT NCT00793403)

NCT ID: NCT00793403

Last Updated: 2013-02-04

Results Overview

Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(\<=)1;swollen joint count(SJC)\<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)\<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) \<=1 (assessed on 0-10 centimeter\[cm\] visual analog scale\[VAS\]) or 2) participant had Simplified Disease Activity Index score of \<=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment \[PGA, assessed on 0-10 cm VAS\], and CRP \[mg/dL\]).

• Recruitment status: COMPLETED
• Target enrollment: 293 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2013-02-04

Participant Flow

Participant milestones

Measure	All Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Overall Study STARTED	293
Overall Study COMPLETED	220
Overall Study NOT COMPLETED	73

Reasons for withdrawal

Measure	All Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Overall Study Other	73

Baseline Characteristics

Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study

Baseline characteristics by cohort

Measure	All Participants n=220 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Age Continuous	55.65 Years STANDARD_DEVIATION 12.18 • n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(<=)1;swollen joint count(SJC)<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) <=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had Simplified Disease Activity Index score of <=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment [PGA, assessed on 0-10 cm VAS], and CRP [mg/dL]).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC <=1; SJC <=1 (TJC, SJC based on 28-joints); CRP <=1 mg/dL; PtGA<=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had SDAI score of <=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA [assessed on 0-10 cm VAS], and CRP [mg/dL]).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) <=20 millimeter per hour (mm/hr).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR <=20 mm/hr.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

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.

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.

Outcome measures

Measure	All Participants n=217 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6 SJC	2.80 Joints Standard Deviation 3.84
Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6 TJC	4.62 Joints Standard Deviation 5.01

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

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.

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.

Outcome measures

Measure	All Participants n=155 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12 SJC	1.28 Joints Standard Deviation 2.72
Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12 TJC	2.35 Joints Standard Deviation 3.47

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.

Outcome measures

Measure	All Participants n=217 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6	3.26 Units on a scale Standard Deviation 1.78

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.

Outcome measures

Measure	All Participants n=137 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12	2.83 Units on a scale Standard Deviation 1.89

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.

Outcome measures

Measure	All Participants n=215 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Clinical Arthritis Activity (CLARA) Index at Month 6	1.79 Units on a scale Standard Deviation 1.37

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.

Outcome measures

Measure	All Participants n=137 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Clinical Arthritis Activity (CLARA) Index at Month 12	1.39 Units on a scale Standard Deviation 1.33

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly.

Outcome measures

Measure	All Participants n=219 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Patient Global Assessment (PtGA) of Disease Activity at Month 6	3.71 cm Standard Deviation 2.23

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly.

Outcome measures

Measure	All Participants n=143 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Patient Global Assessment (PtGA) of Disease Activity at Month 12	3.35 cm Standard Deviation 2.21

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.

Outcome measures

Measure	All Participants n=219 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Physician Global Assessment (PGA) of Disease Activity at Month 6	3.11 cm Standard Deviation 2.04

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.

Outcome measures

Measure	All Participants n=147 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Physician Global Assessment (PGA) of Disease Activity at Month 12	2.60 cm Standard Deviation 1.95

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Measure	All Participants n=184 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
C-reactive Protein (CRP) at Month 6	2.16 mg/dL Standard Deviation 4.07

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Measure	All Participants n=136 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
C-reactive Protein (CRP) at Month 12	1.63 mg/dL Standard Deviation 2.25

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

Outcome measures

Measure	All Participants n=200 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Erythrocyte Sedimentation Rate (ESR) at Month 6	26.02 mm/hr Standard Deviation 19.19

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

Outcome measures

Measure	All Participants n=152 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Erythrocyte Sedimentation Rate (ESR) at Month 12	21.92 mm/hour Standard Deviation 15.65

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Participants answered: "How would you describe your general health today?" Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Participants answered: "How would you describe your general health today?" Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.

Outcome measures

Measure	All Participants n=219 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Patient Assessment of Arthritis Pain at Month 6	3.58 cm Standard Deviation 2.31

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.

Outcome measures

Measure	All Participants n=143 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Patient Assessment of Arthritis Pain at Month 12	3.29 cm Standard Deviation 2.31

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Measure	All Participants n=218 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Health Assessment Questionnaire (HAQ) at Month 6	0.83 Units on a scale Standard Deviation 0.65

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Measure	All Participants n=139 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Health Assessment Questionnaire (HAQ) at Month 12	0.68 Units on a scale Standard Deviation 0.66

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.

Outcome measures

Measure	All Participants n=218 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Recent-Onset Arthritis Disability (ROAD) at Month 6	2.28 Units on a scale Standard Deviation 1.88

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants who were enrolled in the study. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.

Outcome measures

Measure	All Participants n=138 Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
Recent-Onset Arthritis Disability (ROAD) at Month 12	1.97 Units on a scale Standard Deviation 1.92

PRIMARY outcome

Timeframe: Month 6

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.

SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=293 participants at risk Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
General disorders Hospitalization for dermatitis	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Local aedematous reaction, hard and pain	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Suspect of feocromocitoma	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	All Participants n=293 participants at risk Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
General disorders Skin rash on abdomen and chest	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Foot finger infection	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Visus disorder	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Erythematous reaction in the injection site	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Vasculite episode	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Defluvium Capillorum	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Cystitis with fever	0.34% 1/293 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER