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CompletedNCT02349451Updated Aug 4, 2017Results posted

A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)

A Phase 2 interventional study of adalimumab and ABT-122 in Psoriatic Arthritis, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment.

02

Conditions studied

  • Psoriatic Arthritis

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Keywords

  • Safety
  • Efficacy
  • Methotrexate
03

In context

Arthritis, Psoriatic

594 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.

This study's enrollment of 240 is above the median of 138 across 329 interventional studies indexed under Arthritis, Psoriatic.

Browse Arthritis, Psoriatic studies →

Lead sponsor

AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Browse AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • PsA diagnosis of at least 3 months duration prior to the date of first screening with ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.
  • Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas other than the axilla or groin.

  • Have active arthritis defined by minimum disease activity criteria:

    1. >= 3 swollen joints (based on 66 joint counts) at Screening
    2. >= 3 tender joints (based on 68 joint counts) at Screening

  • On a stable dose of methotrexate (MTX) defined as:

    1. Oral or parenteral treatment >= 3 months
    2. On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline
    3. Stable MTX dose of >= 10 mg/week and \<= the upper limit of the applicable approved local label
    4. Can also be on stable doses of nonsteroidal anti-inflammatory drugs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate

Exclusion criteria

Exclusion Criteria:

  • Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.
  • Subjects on prior adalimumab may not be enrolled in the study
  • Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the baseline visit.

  • Current treatment with traditional oral/intramuscular DMARDs, including conventional synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.

    a. Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5 half-lives.

  • Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of the Baseline visit.
  • Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.

  • Laboratory values of the following at the Screening Visit:

    1. Confirmed hemoglobin \< 9 g/dL for males and \< 8.5 g/dL for females
    2. Absolute neutrophil count (ANC) \< 1500 mm\^3, (or \< 1200 cells/µL for subjects of African descent who are black)
    3. Aspartate aminotransferase or alanine aminotransferase > 1.5 x the upper limit of normal (ULN) or bilirubin >= 3 mg/dL
    4. Serum creatinine > 1.5 x the ULN
    5. Platelets \< 100,000 cells/[mm\^3] (10\^9/L),
    6. Clinically significant abnormal screening laboratory results as evaluated by the Investigator
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    Adalimumab

    Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks

    Biological: adalimumab

  • Placebo comparator
    Placebo

    Double-blind placebo administered every week (EW) for 12 weeks

    Biological: ABT-122

  • Experimental
    ABT-122 120 mg

    Double-blind ABT-122 120 mg administered EW for 12 weeks

    Biological: ABT-122

  • Experimental
    ABT-122 240 mg

    Double-blind ABT-122 240 mg administered EW for 12 weeks

    Biological: ABT-122

Interventions

  • Biologicaladalimumab

    Also known as: Humira, ABT-D2E7

  • BiologicalABT-122

    Also known as: remtolumab

06

What researchers measure

Primary outcomes

  1. American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo

    Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein \[hsCRP\]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

    Time frame: Week 12

Secondary outcomes

  1. ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab

    Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

    Time frame: Week 12

  2. ACR50 Response Rate at Week 12

    Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

    Time frame: Week 12

  3. ACR70 Response Rate at Week 12

    Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

    Time frame: Week 12

  4. ACRn at Week 12

    ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.

    Time frame: At Week 12

  5. Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12

    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.

    Time frame: Baseline, Week 12

  6. Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12

    PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.

    Time frame: Baseline, Week 12

  7. Change From Baseline in Psoriasis Target Lesion Score at Week 12

    Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).

    Time frame: Baseline, Week 12

07

Results

Posted Aug 4, 2017

Participant flow

Participant flow — Overall Study
MilestonePlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
Started24727173
Completed24716972
Not completed0121
Withdrew: Withdrawal by subject0121

Outcome measures

PrimaryAmerican College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo

Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein \[hsCRP\]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Time frame:
Week 12
Reported as:
Number · percentage of participants
American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo
percentage of participantsPlacebo EWABT-122 120 mg EWABT-122 240 mg EW
American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo25.0 (11.7 to 45.2)64.8 (53.2 to 74.9)75.3 (64.3 to 83.9)
Statistical analysis
  • Placebo EW vs ABT-122 120 mg EW · Fisher Exact · p = <0.001 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.) · Response rate difference: 39.8 · 95% CI 17.2 to 57.7
  • Placebo EW vs ABT-122 240 mg EW · Fisher Exact · p = <0.001 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.) · Response rate difference: 50.3 · 95% CI 28.1 to 67.4
SecondaryACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab

Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Time frame:
Week 12
Reported as:
Number · percentage of participants
ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab
percentage of participantsAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab68.1 (56.6 to 77.7)64.8 (53.2 to 74.9)75.3 (64.3 to 83.9)
Statistical analysis
  • Adalimumab 40 mg EOW vs ABT-122 120 mg EW · Fisher Exact · p = 0.723 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.) · Response rate difference: -3.3 · 95% CI -18.5 to 12.1
  • Adalimumab 40 mg EOW vs ABT-122 240 mg EW · Fisher Exact · p = 0.215 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.) · Response rate difference: 7.3 · 95% CI -7.4 to 21.6
SecondaryACR50 Response Rate at Week 12

Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Time frame:
Week 12
Reported as:
Number · percentage of participants
ACR50 Response Rate at Week 12
percentage of participantsPlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
ACR50 Response Rate at Week 1212.5 (3.5 to 31.8)37.5 (27.2 to 49.1)36.6 (26.3 to 48.3)53.4 (42.1 to 64.4)
Statistical analysis
  • Placebo EW vs ABT-122 120 mg EW · Fisher Exact · p = 0.021 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.) · Response rate difference: 24.1 · 95% CI 3.9 to 39.3
  • Adalimumab 40 mg EOW vs ABT-122 120 mg EW · Fisher Exact · p = 0.611 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.) · Response rate difference: -0.9 · 95% CI -16.5 to 14.8
  • Placebo EW vs ABT-122 240 mg EW · Fisher Exact · p = <0.001 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.) · Response rate difference: 40.9 · 95% CI 20.1 to 55.8
  • Adalimumab 40 mg EOW vs ABT-122 240 mg EW · Fisher Exact · p = 0.039 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.) · Response rate difference: 15.9 · 95% CI -0.3 to 31.3
SecondaryACR70 Response Rate at Week 12

Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.

Time frame:
Week 12
Reported as:
Number · percentage of participants
ACR70 Response Rate at Week 12
percentage of participantsPlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
ACR70 Response Rate at Week 124.2 (0.0 to 21.9)15.3 (8.6 to 25.5)22.5 (14.3 to 33.6)31.5 (22.0 to 42.9)
Statistical analysis
  • Placebo EW vs ABT-122 120 mg EW · Fisher Exact · p = 0.034 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.) · Response rate difference: 18.4 · 95% CI 1.5 to 29.7
  • Adalimumab 40 mg EOW vs ABT-122 120 mg EW · Fisher Exact · p = 0.185 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.) · Response rate difference: 7.3 · 95% CI -5.8 to 19.9
  • Placebo EW vs ABT-122 240 mg EW · Fisher Exact · p = 0.004 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.) · Response rate difference: 27.3 · 95% CI 9.6 to 39.0
  • Adalimumab 40 mg EOW vs ABT-122 240 mg EW · Fisher Exact · p = 0.017 (P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.) · Response rate difference: 16.2 · 95% CI 2.3 to 29.3
SecondaryACRn at Week 12

ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.

Time frame:
At Week 12
Reported as:
Mean · percentage improvement
ACRn at Week 12
percentage improvementPlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
ACRn at Week 12-20.3 (-59.6 to 19.1)38.2 (29.2 to 47.2)34.7 (25.5 to 44.0)48.6 (41.1 to 56.1)
Statistical analysis
  • Placebo EW vs ABT-122 120 mg EW · Kolmogorov-Smirnov test · p = <0.001 (Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.)
  • Adalimumab 40 mg EOW vs ABT-122 120 mg EW · Kolmogorov-Smirnov test · p = 0.561 (Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.)
  • Placebo EW vs ABT-122 240 mg EW · Kolmogorov-Smirnov test · p = <0.001 (Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.)
  • Adalimumab 40 mg EOW vs ABT-122 240 mg EW · Kolmogorov-Smirnov test · p = 0.106 (Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.)
SecondaryChange From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12
units on a scalePlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12-0.89 (-1.32 to -0.45)-1.83 (-2.08 to -1.58)-1.96 (-2.21 to -1.70)-2.28 (-2.53 to -2.03)
Statistical analysis
  • Placebo EW vs ABT-122 120 mg EW · ANCOVA · p = <0.001 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -1.07 · 95% CI -1.58 to -0.57
  • Adalimumab 40 mg EOW vs ABT-122 120 mg EW · ANCOVA · p = 0.479 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -0.13 · 95% CI -0.48 to 0.23
  • Placebo EW vs ABT-122 240 mg EW · ANCOVA · p = <0.001 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -1.40 · 95% CI -1.90 to -0.89
  • Adalimumab 40 mg EOW vs ABT-122 240 mg EW · ANCOVA · p = 0.012 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -0.45 · 95% CI -0.81 to -0.10
SecondaryChange From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12

PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12
units on a scalePlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12-1.46 (-2.01 to -0.90)-2.53 (-2.85 to -2.22)-2.62 (-2.94 to -2.31)-2.86 (-3.18 to -2.55)
Statistical analysis
  • Placebo EW vs ABT-122 120 mg EW · ANCOVA · p = <0.001 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -1.17 · 95% CI -1.81 to -0.53
  • Adalimumab 40 mg EOW vs ABT-122 120 mg EW · ANCOVA · p = 0.696 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -0.09 · 95% CI -0.54 to 0.36
  • Placebo EW vs ABT-122 240 mg EW · ANCOVA · p = <0.001 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -1.41 · 95% CI -2.04 to -0.77
  • Adalimumab 40 mg EOW vs ABT-122 240 mg EW · ANCOVA · p = 0.151 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -0.33 · 95% CI -0.77 to 0.12
SecondaryChange From Baseline in Psoriasis Target Lesion Score at Week 12

Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in Psoriasis Target Lesion Score at Week 12
units on a scalePlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
Change From Baseline in Psoriasis Target Lesion Score at Week 12-1.81 (-2.65 to -0.96)-4.16 (-4.65 to -3.67)-4.98 (-5.47 to -4.49)-4.53 (-5.02 to -4.05)
Statistical analysis
  • Placebo EW vs ABT-122 120 mg EW · ANCOVA · p = <0.001 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -3.17 · 95% CI -4.14 to -2.19
  • Adalimumab 40 mg EOW vs ABT-122 120 mg EW · ANCOVA · p = 0.021 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -0.81 · 95% CI -1.51 to -0.12
  • Placebo EW vs ABT-122 240 mg EW · ANCOVA · p = <0.001 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -2.73 · 95% CI -3.70 to -1.75
  • Adalimumab 40 mg EOW vs ABT-122 240 mg EW · ANCOVA · p = 0.288 (Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.) · Least squares mean difference: -0.37 · 95% CI -1.06 to 0.32

Adverse events

Collected over Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo EW—1/24 (4.2%)10/24 (41.7%)
Adalimumab 40 mg EOW—0/72 (0%)39/72 (54.2%)
ABT-122 120 mg EW—0/71 (0%)33/71 (46.5%)
ABT-122 240 mg EW—1/73 (1.4%)33/73 (45.2%)
Most frequent serious events
Most frequent serious events
EventPlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
ROAD TRAFFIC ACCIDENTInjury, poisoning and procedural complications1/240/720/710/73
SKIN ABRASIONInjury, poisoning and procedural complications1/240/720/710/73
UPPER LIMB FRACTUREInjury, poisoning and procedural complications1/240/720/710/73
HEART RATE DECREASEDInvestigations0/240/720/711/73
SYNCOPENervous system disorders0/240/720/711/73
Most frequent other events
Showing 10 of 136
Most frequent other events
EventPlacebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EW
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations2/245/721/717/73
NASOPHARYNGITISInfections and infestations0/246/724/713/73
BACK PAINMusculoskeletal and connective tissue disorders2/240/720/711/73
ALANINE AMINOTRANSFERASE INCREASEDInvestigations0/242/725/713/73
URINARY TRACT INFECTIONInfections and infestations0/241/722/714/73
ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations0/241/723/712/73
DIARRHOEAGastrointestinal disorders1/241/721/710/73
NAUSEAGastrointestinal disorders1/240/721/711/73
INJECTION SITE ERYTHEMAGeneral disorders0/243/721/712/73
VESSEL PUNCTURE SITE PHLEBITISGeneral disorders1/240/720/710/73

Baseline characteristics

Full Analysis Set: randomized participants who received at least 1 dose of study medication.

Age, Continuous
Age, Continuous(years)Placebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EWTotal
Mean47.7 ± 13.6750.5 ± 12.0351.0 ± 12.3947.4 ± 13.7749.4 ± 12.87
Sex: Female, Male
Sex: Female, Male(Participants)Placebo EWAdalimumab 40 mg EOWABT-122 120 mg EWABT-122 240 mg EWTotal
Female12333737119
Male12393436121
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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312. PubMed 30376130 ↗
  • Mease PJ, Genovese MC, Weinblatt ME, Peloso PM, Chen K, Othman AA, Li Y, Mansikka HT, Khatri A, Wishart N, Liu J. Phase II Study of ABT-122, a Tumor Necrosis Factor- and Interleukin-17A-Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2018 Nov;70(11):1778-1789. doi: 10.1002/art.40579. PubMed 29855175 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2015 to primary completion in Jul 2016, 14 months.

Results were first posted in Aug 2017, 1 year 1 month after primary completion.

Of 33 phase 2 interventional studies under Arthritis, Psoriatic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2015
First posted
Jan 28, 2015
StartActual
Apr 28, 2015
Primary completionActual
Jul 4, 2016
CompletionActual
Jul 4, 2016
Results first posted
Aug 4, 2017
Last update
Aug 4, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02349451
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jan 28, 2015
Start date
Apr 28, 2015
Primary completion
Jul 4, 2016
Completion
Jul 4, 2016
Results posted
Aug 4, 2017
Last update
Aug 4, 2017

Study contacts

Paul Peloso, MD
study director · AbbVie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: ABT-122

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