A Phase 2 interventional study of TRU-015 and Methylprednisolone in Arthritis, Rheumatoid, sponsored by Pfizer. Terminated at 65 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-11.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 222 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Consists of Arms 1a and 1b
Drug: TRU-015 · Drug: Methylprednisolone · Drug: Prednisone
Consists of Arms 2a and 2b
Drug: TRU-015 · Drug: Methylprednisolone · Drug: Prednisone
Consists of Arms 3a and 3b.
Drug: TRU-015 · Drug: Methylprednisolone · Drug: Prednisone
IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)
IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).
IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).
Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and C-Reactive Protein (CRP).
Time frame: Week 24
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
Time frame: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Number of Tender Joints
The 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.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Number of Swollen Joints
The 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.
Time frame: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Duration of Morning Stiffness
Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Visual Analogue Scale for Pain (VAS-pain)
100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Physician Global Assessment (PGA) of Disease Activity
Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Patient Global Assessment (PtGA) of Disease Activity
Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
General Health Visual Analog Scale (VAS)
100 mm line (VAS) marked by participant. Participants were asked, "How do you feel concerning your arthritis?" Total possible score range, 0 mm = very well to 100 mm = extremely bad.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Health Assessment Questionnaire Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index 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.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Disease Activity Score Based on 28-joints Count (DAS28)
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and participant's general health visual analog scale (scores ranging 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 less than or equal to (=\<) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
36-Item Short-Form Health Survey (SF-36)
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Baseline, Week 12, 24, 36, 52
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Week 12, 24, 36, 52
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Week 12, 24, 36, 52
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time frame: Baseline, Week 12, 24, 36, 52
Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score
WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.
Time frame: Baseline, Week 12, 24, 36, 52
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.
Time frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
| Milestone | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose | Placebo/TRU-015 Single Dose | Placebo/TRU-015 Induction Dose |
|---|---|---|---|---|---|
| Started | 74 | 75 | 73 | 0 | 0 |
| Completed | 63 | 57 | 55 | 0 | 0 |
| Not completed | 11 | 18 | 18 | 0 | 0 |
| Withdrew: Adverse event | 4 | 4 | 8 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Failed to return | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Investigator request | 1 | 1 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 3 | 3 | 0 | 0 |
| Withdrew: Lack of efficacy | 3 | 1 | 0 | 0 | 0 |
| Withdrew: Other | 1 | 8 | 5 | 0 | 0 |
| Milestone | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose | Placebo/TRU-015 Single Dose | Placebo/TRU-015 Induction Dose |
|---|---|---|---|---|---|
| Started | 0 | 57 | 55 | 31 | 32 |
| Completed | 0 | 56 | 55 | 31 | 32 |
| Not completed | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 |
| Milestone | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose | Placebo/TRU-015 Single Dose | Placebo/TRU-015 Induction Dose |
|---|---|---|---|---|---|
| Started | 0 | 56 | 55 | 31 | 32 |
| Completed | 0 | 42 | 33 | 25 | 22 |
| Not completed | 0 | 14 | 22 | 6 | 10 |
| Withdrew: Adverse event | 0 | 1 | 1 | 1 | 0 |
| Withdrew: Discontinuation of study by sponsor | 0 | 11 | 14 | 3 | 7 |
| Withdrew: Physician decision | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 5 | 0 | 1 |
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and C-Reactive Protein (CRP).
| percentage of participants | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24 | 16.2 | 29.3 | 27.4 |
ACR20 response: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
| percentage of participants | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Week 2 | 17.6 | 21.3 | 26.0 |
| Week 4 | 31.1 | 34.7 | 34.2 |
| Week 8 | 31.1 | 44.0 | 42.5 |
| Week 12 | 31.1 | 52.0 | 49.3 |
| Week 16 | 41.9 | 64.0 | 61.6 |
| Week 20 | 47.3 | 62.7 | 64.4 |
| Week 24 | 43.2 | 61.3 | 67.1 |
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
| percentage of participants | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Week 2 | 0.0 | 8.0 | 6.8 |
| Week 4 | 6.8 | 8.0 | 6.8 |
| Week 8 | 12.2 | 10.7 | 8.2 |
| Week 12 | 14.9 | 16.0 | 13.7 |
| Week 16 | 16.2 | 30.7 | 31.5 |
| Week 20 | 16.2 | 28.0 | 28.8 |
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
| percentage of participants | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Week 2 | 0.0 | 1.3 | 1.4 |
| Week 4 | 1.4 | 1.3 | 0.0 |
| Week 8 | 1.4 | 2.7 | 1.4 |
| Week 12 | 1.4 | 2.7 | 2.7 |
| Week 16 | 6.8 | 8.0 | 6.8 |
| Week 20 | 2.7 | 6.7 | 6.8 |
| Week 24 | 2.7 | 9.3 | 9.6 |
The 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.
| tender joints | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Baseline | 17.0 ± 6.1 | 16.8 ± 7.0 | 17.7 ± 6.2 |
| Week 2 | 13.6 ± 7.0 | 11.9 ± 7.4 | 13.0 ± 7.7 |
| Week 4 | 11.9 ± 7.0 | 10.7 ± 7.7 | 11.6 ± 7.7 |
| Week 8 | 11.7 ± 8.4 | 9.8 ± 6.7 | 10.1 ± 7.4 |
| Week 12 | 11.0 ± 7.9 | 8.8 ± 6.9 | 9.6 ± 7.7 |
| Week 16 | 9.4 ± 7.9 | 7.3 ± 7.0 | 8.4 ± 7.2 |
| Week 20 | 9.0 ± 7.2 | 7.6 ± 7.3 | 7.6 ± 7.1 |
| Week 24 | 9.4 ± 7.5 | 8.1 ± 7.6 | 7.6 ± 7.4 |
The 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.
| swollen joints | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Baseline | 12.2 ± 4.4 | 12.3 ± 6.0 | 13.9 ± 5.7 |
| Week 2 | 9.5 ± 5.7 | 9.0 ± 6.5 | 10.2 ± 6.2 |
| Week 4 | 7.8 ± 5.3 | 8.5 ± 6.4 | 9.0 ± 6.2 |
| Week 8 | 7.0 ± 5.7 | 6.9 ± 5.2 | 7.7 ± 5.6 |
| Week 12 | 7.6 ± 5.8 | 6.0 ± 4.9 | 7.1 ± 5.5 |
| Week 16 | 6.1 ± 5.4 | 5.1 ± 5.2 | 5.9 ± 4.7 |
| Week 20 | 6.0 ± 5.4 | 4.8 ± 4.6 | 5.1 ± 4.9 |
| Week 24 | 6.2 ± 5.5 | 4.7 ± 4.6 | 5.0 ± 5.0 |
Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes \[24 hours\*60 minutes\] was recorded).
No measurements were reported for this outcome.
100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.
| mm | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Baseline | 65.4 ± 17.9 | 62.5 ± 20.7 | 61.6 ± 23.0 |
| Week 2 | 53.0 ± 21.2 | 47.7 ± 25.2 | 49.6 ± 24.6 |
| Week 4 | 53.6 ± 20.3 | 48.9 ± 25.9 | 49.0 ± 24.2 |
| Week 8 | 56.4 ± 23.0 | 45.8 ± 24.0 | 47.0 ± 24.5 |
| Week 12 | 54.3 ± 21.6 | 42.3 ± 24.1 | 44.8 ± 25.4 |
| Week 16 | 51.1 ± 24.2 | 39.3 ± 24.4 | 40.8 ± 25.2 |
| Week 20 | 51.1 ± 21.6 | 39.5 ± 24.2 | 39.1 ± 25.7 |
| Week 24 | 49.2 ± 22.2 | 39.2 ± 25.0 | 43.9 ± 28.3 |
Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.
| units on a scale | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Baseline | 6.8 ± 1.3 | 6.4 ± 1.6 | 6.6 ± 1.7 |
| Week 2 | 5.5 ± 1.5 | 5.1 ± 2.2 | 5.2 ± 1.9 |
| Week 4 | 5.0 ± 1.9 | 5.0 ± 2.3 | 4.9 ± 2.1 |
| Week 8 | 5.0 ± 2.2 | 4.1 ± 2.1 | 4.4 ± 2.1 |
| Week 12 | 4.8 ± 2.1 | 4.1 ± 2.1 | 4.3 ± 2.3 |
| Week 16 | 4.6 ± 2.4 | 3.7 ± 2.1 | 3.6 ± 2.1 |
| Week 20 | 4.4 ± 2.1 | 3.8 ± 1.8 | 3.6 ± 2.2 |
| Week 24 | 4.3 ± 2.2 | 3.7 ± 2.1 | 3.6 ± 2.4 |
Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.
| units on a scale | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Baseline | 7.3 ± 1.6 | 6.9 ± 1.9 | 7.0 ± 2.3 |
| Week 2 | 6.2 ± 2.1 | 5.6 ± 2.4 | 5.6 ± 2.3 |
| Week 4 | 6.0 ± 1.8 | 5.4 ± 2.4 | 5.6 ± 2.4 |
| Week 8 | 6.2 ± 2.1 | 5.2 ± 2.4 | 5.3 ± 2.3 |
| Week 12 | 5.9 ± 2.1 | 4.8 ± 2.3 | 5.2 ± 2.4 |
| Week 16 | 6.6 ± 9.2 | 4.4 ± 2.3 | 4.6 ± 2.5 |
| Week 20 | 5.5 ± 2.1 | 4.5 ± 2.3 | 4.5 ± 2.4 |
| Week 24 | 5.3 ± 2.0 | 4.6 ± 2.3 | 4.7 ± 2.7 |
100 mm line (VAS) marked by participant. Participants were asked, "How do you feel concerning your arthritis?" Total possible score range, 0 mm = very well to 100 mm = extremely bad.
No measurements were reported for this outcome.
HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index 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.
| units on a scale | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Baseline | 1.8 ± 0.6 | 1.7 ± 0.6 | 1.6 ± 0.7 |
| Week 2 | 1.5 ± 0.6 | 1.4 ± 0.7 | 1.3 ± 0.6 |
| Week 4 | 1.4 ± 0.7 | 1.4 ± 0.7 | 1.3 ± 0.7 |
| Week 8 | 1.5 ± 0.7 | 1.3 ± 0.6 | 1.2 ± 0.7 |
| Week 12 | 1.5 ± 0.7 | 1.3 ± 0.6 | 1.1 ± 0.7 |
| Week 16 | 1.4 ± 0.7 | 1.2 ± 0.6 | 1.1 ± 0.7 |
| Week 20 | 1.4 ± 0.7 | 1.2 ± 0.7 | 1.0 ± 0.8 |
| Week 24 | 1.4 ± 0.6 | 1.2 ± 0.7 | 1.0 ± 0.8 |
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and participant's general health visual analog scale (scores ranging 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 less than or equal to (=\<) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity.
| units on a scale | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Baseline | 6.1 ± 0.7 | 5.8 ± 0.9 | 6.1 ± 1.0 |
| Week 2 | 5.4 ± 1.0 | 5.1 ± 1.3 | 5.3 ± 1.3 |
| Week 4 | 5.2 ± 1.1 | 4.9 ± 1.4 | 5.0 ± 1.4 |
| Week 8 | 5.1 ± 1.3 | 4.6 ± 1.3 | 4.7 ± 1.3 |
| Week 12 | 5.0 ± 1.3 | 4.3 ± 1.3 | 4.6 ± 1.4 |
| Week 16 | 4.7 ± 1.5 | 3.9 ± 1.4 | 4.3 ± 1.4 |
| Week 20 | 4.7 ± 1.4 | 4.0 ± 1.3 | 4.1 ± 1.4 |
| Week 24 | 4.7 ± 1.4 | 4.1 ± 1.3 | 4.0 ± 1.5 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
No measurements were reported for this outcome.
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state.
No measurements were reported for this outcome.
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
No measurements were reported for this outcome.
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
No measurements were reported for this outcome.
WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.
No measurements were reported for this outcome.
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.
| percentage of participants | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose |
|---|---|---|---|
| Week 2: good response | 1.4 | 6.7 | 2.7 |
| Week 2: moderate response | 33.8 | 38.7 | 39.7 |
| Week 2: no response | 64.9 | 54.7 | 57.5 |
| Week 4: good response | 5.4 | 14.7 | 8.2 |
| Week 4: moderate response | 39.2 | 41.3 | 45.2 |
| Week 4: no response | 55.4 | 44.0 | 46.6 |
| Week 8: good response | 8.1 | 14.7 | 12.3 |
| Week 8: moderate response | 44.6 | 44.0 | 53.4 |
| Week 8: no response | 47.3 | 41.3 | 34.2 |
| Week 12: good response | 9.5 | 21.3 | 16.4 |
| Week 12: moderate response | 39.2 | 53.3 | 52.1 |
| Week 12: no response | 51.4 | 25.3 | 31.5 |
| Week 16: good response | 18.9 | 34.7 | 20.5 |
| Week 16: moderate response | 40.5 | 41.3 | 56.2 |
| Week 16: no response | 40.5 | 24.0 | 23.3 |
| Week 20: good response | 17.6 | 29.3 | 26.0 |
| Week 20: moderate response | 37.8 | 52.0 | 54.8 |
| Week 20: no response | 44.6 | 18.7 | 19.2 |
| Week 24: good response | 14.9 | 26.7 | 30.1 |
| Week 24: moderate response | 44.6 | 46.7 | 50.7 |
| Week 24: no response | 40.5 | 26.7 | 19.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (Part A) | — | 7/74 (9.5%) | 25/74 (33.8%) |
| TRU-015 Single Dose (Part A) | — | 4/75 (5.3%) | 27/75 (36%) |
| TRU-015 Induction Dose (Part A) | — | 7/73 (9.6%) | 25/73 (34.2%) |
| TRU-015 Single Dose (Part B) | — | 2/56 (3.6%) | 22/56 (39.3%) |
| TRU-015 Induction Dose (Part B) | — | 2/55 (3.6%) | 12/55 (21.8%) |
| Placebo/TRU-015 Single Dose (Part B) | — | 0/31 (0%) | 18/31 (58.1%) |
| Placebo/TRU-015 Induction Dose (Part B) | — | 0/32 (0%) | 14/32 (43.8%) |
| Event | Placebo (Part A) | TRU-015 Single Dose (Part A) | TRU-015 Induction Dose (Part A) | TRU-015 Single Dose (Part B) | TRU-015 Induction Dose (Part B) | Placebo/TRU-015 Single Dose (Part B) | Placebo/TRU-015 Induction Dose (Part B) |
|---|---|---|---|---|---|---|---|
| BronchitisInfections and infestations | 0/74 | 0/75 | 2/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| Cholecystitis chronicHepatobiliary disorders | 2/74 | 0/75 | 0/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| H1N1 influenzaInfections and infestations | 0/74 | 0/75 | 0/73 | 0/56 | 1/55 | 0/31 | 0/32 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/74 | 0/75 | 0/73 | 0/56 | 1/55 | 0/31 | 0/32 |
| AppendicitisInfections and infestations | 0/74 | 0/75 | 0/73 | 1/56 | 0/55 | 0/31 | 0/32 |
| Joint sprainInjury, poisoning and procedural complications | 0/74 | 0/75 | 0/73 | 1/56 | 0/55 | 0/31 | 0/32 |
| Atrial fibrillationCardiac disorders | 0/74 | 0/75 | 1/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| Hip fractureInjury, poisoning and procedural complications | 0/74 | 0/75 | 1/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| BursitisMusculoskeletal and connective tissue disorders | 0/74 | 0/75 | 1/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| PregnancyPregnancy, puerperium and perinatal conditions | 0/74 | 1/75 | 1/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| Event | Placebo (Part A) | TRU-015 Single Dose (Part A) | TRU-015 Induction Dose (Part A) | TRU-015 Single Dose (Part B) | TRU-015 Induction Dose (Part B) | Placebo/TRU-015 Single Dose (Part B) | Placebo/TRU-015 Induction Dose (Part B) |
|---|---|---|---|---|---|---|---|
| Urinary tract infectionInfections and infestations | 5/74 | 6/75 | 5/73 | 8/56 | 3/55 | 6/31 | 4/32 |
| RashSkin and subcutaneous tissue disorders | 0/74 | 4/75 | 10/73 | 3/56 | 2/55 | 3/31 | 2/32 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/74 | 0/75 | 0/73 | 4/56 | 0/55 | 3/31 | 1/32 |
| HeadacheNervous system disorders | 7/74 | 4/75 | 6/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| Upper respiratory tract infectionInfections and infestations | 0/74 | 0/75 | 0/73 | 4/56 | 1/55 | 2/31 | 3/32 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/74 | 5/75 | 0/73 | 2/56 | 1/55 | 1/31 | 3/32 |
| PruritusSkin and subcutaneous tissue disorders | 2/74 | 7/75 | 5/73 | 1/56 | 0/55 | 1/31 | 3/32 |
| UrticariaSkin and subcutaneous tissue disorders | 1/74 | 1/75 | 5/73 | 0/56 | 0/55 | 0/31 | 0/32 |
| Infusion related reactionGeneral disorders | 0/74 | 0/75 | 0/73 | 0/56 | 1/55 | 2/31 | 0/32 |
| BronchitisInfections and infestations | 4/74 | 2/75 | 0/73 | 1/56 | 1/55 | 2/31 | 0/32 |
| Age Continuous(years) | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose | Total |
|---|---|---|---|---|
| Mean | 50.62 ± 11.07 | 52.99 ± 11.33 | 52.55 ± 13.00 | 52.05 ± 11.81 |
| Sex: Female, Male(Participants) | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose | Total |
|---|---|---|---|---|
| Female | 64 | 62 | 59 | 185 |
| Male | 10 | 13 | 14 | 37 |
The record gives a start of Mar 2008, a primary completion of Feb 2010 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2013, 3 years 1 month after primary completion. A results delay was requested in Jul 2012.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: TRU-015