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A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL) (CONTROL)

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ClinicalTrials.gov Identifier: NCT02814175
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: methotrexate (MTX)
Biological: adalimumab (ADA)
Enrollment 246
Recruitment Details There were 246 participants randomized; 1 participant did not receive study medication. Upon completion of Part 1, eligible participants continued to Part 2, so no additional participants were enrolled in Part 2.
Pre-assignment Details Intent-To-Treat Part 1 (ITT Part 1) population comprised all participants randomized and received at least 1 dose of study medication in Part 1. ITT Long Term (ITT LT) population included all participants who continued to Part 2 and received at least 1 dose of Part 2 study medication; no additional participants were enrolled into Part 2.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX Part 2: MTX Escalated Dose Part 2: ADA +MTX Escalated Dose Part 2: ADA Part 2: ADA ew + MTX
Hide Arm/Group Description Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew) Adalimumab (ADA) 40 mg every other week (eow) in combination with methotrexate (MTX) 15 mg every week (ew) Participants achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 -25 mg or highest tolerable dose every week (ew), continued with the same MTX dose Participants not achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew), received adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 20 - 25 mg or highest tolerable dose ew Participants achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy Participants not achieving minimal disease activity (MDA) at Week 16 on adalimumab (ADA) 40 mg every other week (eow) plus methotrexate (MTX) 15 mg every week (ew), had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Period Title: Part 1
Started 122 123 0 0 0 0
Completed 110 117 0 0 0 0
Not Completed 12 6 0 0 0 0
Reason Not Completed
Adverse Event             2             3             0             0             0             0
Withdrawal Consent             8             1             0             0             0             0
Lost to Follow-up             1             0             0             0             0             0
Lack of Efficacy             1             2             0             0             0             0
Period Title: Part 2
Started 0 0 15 95 54 63
Completed 0 0 15 91 52 57
Not Completed 0 0 0 4 2 6
Reason Not Completed
Adverse Event             0             0             0             1             1             2
Withdrawal Consent             0             0             0             2             1             1
Lost to Follow-up             0             0             0             1             0             0
Lack of Efficacy             0             0             0             0             0             3
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX Total
Hide Arm/Group Description Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew) Adalimumab (ADA) 40 mg every other week (eow) in combination with methotrexate (MTX) 15 mg every week (ew) Total of all reporting groups
Overall Number of Baseline Participants 122 123 245
Hide Baseline Analysis Population Description
The Intent-To-Treat Part 1 (ITT Part 1) population comprises all participants who were randomized and received at least one dose of the study medication during Part 1.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 123 participants 245 participants
48.8  (12.69) 51.4  (12.23) 50.1  (12.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 123 participants 245 participants
Female 59 64 123
Male 63 59 122
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 123 participants 245 participants
Hispanic or Latino 27 27 54
Not Hispanic or Latino 95 96 191
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 123 participants 245 participants
American Indian or Alaska Native 0 0 0
Asian 7 1 8
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 2 2 4
White 111 115 226
More than one race 2 4 6
Unknown or Not Reported 0 0 0
1.Primary Outcome
Title Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)
Hide Description Minimal disease activity (MDA) for psoriatic arthritis (PsA) was defined as fulfilling at least 5 of the following 7 criteria: tender and swollen joint counts (TJC) ≤ 1 (out of TJC68 assessed in this study), swollen joint count (SJC) ≤ 1 (out of SJC66 assessed in this study), Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3; Patient's assessment of pain visual analogue scale (VAS) ≤ 15, Patient's global assessment of disease activity (PtGA) VAS ≤ 20, Health Assessment Questionnaire Disability Index (HAQ-DI) score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat Part 1 (ITT Part 1) population comprises all participants who were randomized and received at least one dose of the study medication during Part 1. Results for binary endpoints are based on non-responder imputation (NRI).
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 122 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.1
(7.1 to 19.1)
41.5
(32.8 to 50.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: MTX Escalated Dose, Part 1: ADA + MTX
Comments [Not Specified]
Type of Statistical Test Other
Comments Between group difference
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for the stratification factor which is the duration of prior MTX 15 mg ew use of ≤ 3 months or > 3 months.
Method of Estimation Estimation Parameter point estimate difference
Estimated Value 28.3
Confidence Interval (2-Sided) 95%
17.8 to 38.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)
Hide Description The Dermatology Life Quality Index (DLQI) score is a measure of participant's quality of life (QOL) related to skin disease.The DLQI questionnaire consists of 10 questions concerning participants' perception of the impact of skin diseases on different aspects of their health related QOL over the last week. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. The range of possible DLQI scores is 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1). Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 109 117
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-3.1
(-3.85 to -2.30)
-5.9
(-6.70 to -5.20)
3.Secondary Outcome
Title Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)
Hide Description Hands and feet bilaterally were assessed for the presence/absence of dactylitis and associated tenderness for participants with presence of dactylitis at baseline. The tender dactylitic digit count is equal to the number of swollen and painful digits (range 0 to 20). A decrease indicates improvement.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 66 62
Least Squares Mean (95% Confidence Interval)
Unit of Measure: count of fingers/ toes with dactylitis
-0.9
(-1.48 to -0.41)
-2.8
(-3.35 to -2.23)
4.Secondary Outcome
Title Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)
Hide Description The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity but is also used in PsA clinical trials. DAS28 is a composite score calculated using a mathematical formula based on the scores for these scales. DAS28 includes tender and swollen joint counts, PtGA, and acute phase reactant (CRP in this study). DAS28 scores range from 0 to 10, with higher scores indicating more disease activity. A larger negative change in the DAS28 score indicates greater improvement.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 108 114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-0.9
(-1.08 to -0.65)
-2.0
(-2.16 to -1.75)
5.Secondary Outcome
Title Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)
Hide Description Psoriatic Arthritis Impact of Disease Score (PsAID) was developed by an European League Against Rheumatism (EULAR) initiative and is a validated patient self-reported tool to assess the impact of PsA on the participant's life. The PsAID is a composite score calculated using a mathematical formula based on the scores for each component. PsAID-9 was developed for clinical trials and was used in this study. The PsAID-9 is calculated based on 9 Numerical rating scales (NRS) questions that include pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, and anxiety). Each NRS is assessed as a number between 0 and 10. PsAID scores range from 0 to 10, with higher scores indicating worse status. A larger negative change in the PsAID-9 score indicates greater improvement.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 107 117
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-1.7
(-2.09 to -1.28)
-3.3
(-3.73 to -2.95)
6.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1)
Hide Description The ACR is a standard criteria originally developed to measure the effectiveness of various arthritis medications or treatments in clinical trials for RA, but is also widely used in PsA. The ACR measures improvement in tender joint count (TJC) or swollen joint count (SJC), and improvement in at least 3 of the following 5 parameters: Patient Global Assessment (PtGA), Physician's Global Assessment of Disease Activity (PhGA), physical function (using HAQ-DI) and acute phase reactant (using CRP). ACR 20/50/70 response is achieved if ≥ 20%/≥ 50%/≥ 70% improvement in tender joint count (TJC) or swollen joint count (SJC) as well as a ≥ 20%/≥ 50%/≥ 70% improvement in ≥ 3 of the other 5 parameters.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 122 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
ACR 20
32.8
(24.5 to 41.1)
67.5
(59.2 to 75.8)
ACR 50
16.4
(9.8 to 23.0)
45.5
(36.7 to 54.3)
ACR 70
8.2
(3.3 to 13.1)
30.9
(22.7 to 39.1)
7.Secondary Outcome
Title Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline
Hide Description The Leeds Enthesitis Index (LEI) is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions for participants with presence of LEI at baseline.Tenderness on examination is recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. A decrease in LEI indicates improvement.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 89 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-1.1
(-1.43 to -0.75)
-1.9
(-2.22 to -1.54)
8.Secondary Outcome
Title Percentage of Participants in MDA in Part 2 of the Study (Week 32)
Hide Description MDA for PsA was defined as fulfilling at least 5 of the following 7 criteria: TJC ≤ 1 (out of TJC68 assessed in this study), SJC ≤ 1 (out of SJC66 assessed in this study), PASI ≤ 1 or BSA ≤ 3; Patient's assessment of pain VAS ≤ 15, PtGA VAS ≤ 20, HAQ-DI score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).
Time Frame Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Long Term (ITT LT) population comprises all participants who continued to Part 2 and received at least one dose of Part 2 study medication. No missing data imputationperformed for long term efficacy analysis except for participants who were rescued, where participants rescued prior to Week 32 are imputed as non-responders.
Arm/Group Title Part 2: MTX Escalated Dose Part 2: ADA + MTX Escalated Dose Part 2: ADA Part 2: ADA ew + MTX
Hide Arm/Group Description:
Participants achieving minimal disease activity (MDA) at Week 16 on methotrexate (MTX) escalated to 20 -25 mg or highest tolerable dose every week (ew), continued with the same MTX dose
Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 20 - 25 mg or highest tolerable dose ew
Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy
Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 15 91 51 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(42.8 to 90.5)
54.9
(44.7 to 65.2)
80.4
(69.5 to 91.3)
29.8
(17.9 to 41.7)
9.Secondary Outcome
Title Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1)
Hide Description

Psoriatic Arthritis Disease Activity Score (PASDAS) is a weighted disease activity measure developed specifically for PsA. It includes PhGA, PtGA, SF-36 PCS, SJC, TJC, Leeds enthesitis count, tender dactylitic count and hsCRP lab test. The PASDAS is a composite score calculated using a mathematical formula based on the scores for each component. 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 From Day 1 to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 105 114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-1.2
(-1.46 to -0.86)
-2.8
(-3.05 to -2.48)
10.Secondary Outcome
Title Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1)
Hide Description The Short Form Health Survey 36 (SF-36) is a generic measure to assess participant's general health/well-being (health related quality of life); short version 2 (SF-36v2) was used. SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise physical component of the SF-36. Scores on each item were summed and averaged (PCS; range = 0-100). Items 5-8 comprise mental component of the SF-36. Scores on each item were summed and averaged (mental component score [MCS]; range = 0-100). Larger values on SF-36 indicate a better condition. A positive change from Baseline in either PCS or MCS indicates improvement.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1)
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 107 117
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
SF-36 PCS
4.4
(3.07 to 5.73)
8.9
(7.58 to 10.15)
SF-36 MCS
1.3
(-0.36 to 2.97)
4.4
(2.85 to 6.05)
11.Secondary Outcome
Title Change in HAQ-DI Score From Baseline (Part 1)
Hide Description The HAQ-DI is a standardized measure of physical function in arthritis. The HAQ-DI questionnaire contains 20 items divided into 8 domains that measure: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 110 116
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-0.3
(-0.39 to -0.21)
-0.5
(-0.60 to -0.42)
12.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1)
Hide Description Psoriasis Area and Severity Index (PASI) provides a quantitative assessment of psoriasis lesional burden based on the amount of body surface area involved and the degree of severity of erythema, induration, and scale, weighted by body part. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. 75/90/100 denotes greater than or equal to 75%/90%/100% improvement in PASI score. A 100% reduction is considered complete clearance of psoriasis.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 87 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PASI 75
31.0
(21.3 to 40.8)
73.1
(63.2 to 82.9)
PASI 90
18.4
(10.3 to 26.5)
57.7
(46.7 to 68.7)
PASI 100
9.2
(3.1 to 15.3)
29.5
(19.4 to 39.6)
13.Secondary Outcome
Title Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1)
Hide Description Disease Activity in Psoriatic Arthritis Score (DAPSA) score is a the sum of swollen joint count (66 joints), tender joint count (68 joints), CRP (mg/dL), Patient's Assessment of Pain (on a 10-unit VAS;0=no pain, 10=worst possible pain), and Patient's Global Assessment of Disease Activity (arthritis, on a 10-unit VAS; 0 to 100 centimeter [cm] VAS, 0=excellent and 10=poor). Change from baseline in DAPSA measures the change in disease activity, where a negative change indicates an improvement and a positive change indicates worsening of disease activity.
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Part 1) Results for binary endpoints are based on NRI. Results for other continuous endpoints are based on MMRM.
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX
Hide Arm/Group Description:
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
Overall Number of Participants Analyzed 108 114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-12.1
(-15.57 to -8.69)
-28.2
(-31.60 to -24.87)
Time Frame All adverse events reported from the time of study medication administration until 70 days following discontinuation of study medication administration have elapsed.
Adverse Event Reporting Description

The Safety population Part 1 included all participants who received at least 1 dose of Part 1 study medication (1 of the 2 treatment arms) and in Part 2, all participants who received at least 1 dose of Part 2 study medication (1 of 4 treatment arms).

Two sets of safety analyses performed using the Safety Population Part 1 and Safety Population Part 2, respectively:

  • Safety analyses during Part 1 (up to Week 16).
  • Safety analyses during Part 2 (Week 16 to Week 32).
 
Arm/Group Title Part 1: MTX Escalated Dose Part 1: ADA + MTX Part 2: MTX Escalated Dose Part 2: ADA + MTX Escalated Dose Part 2: ADA Part 2: ADA ew + MTX
Hide Arm/Group Description Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew) (MTX 20 - 25 mg or highest tolerable dose ew) Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew (ADA 40 mg eow + MTX 15 mg ew Participants achieving MDA at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose (MTX 20 - 25 mg or highest tolerable dose ew) Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew (ADA 40 mg eow plus MTX 20 - 25 mg or highest tolerable dose ew) Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy (ADA 40 mg eow), Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew (ADA 40 mg ew plus MTX 15 mg ew)
All-Cause Mortality
Part 1: MTX Escalated Dose Part 1: ADA + MTX Part 2: MTX Escalated Dose Part 2: ADA + MTX Escalated Dose Part 2: ADA Part 2: ADA ew + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)      0/123 (0.00%)      0/15 (0.00%)      0/95 (0.00%)      0/54 (0.00%)      0/63 (0.00%)    
Hide Serious Adverse Events
Part 1: MTX Escalated Dose Part 1: ADA + MTX Part 2: MTX Escalated Dose Part 2: ADA + MTX Escalated Dose Part 2: ADA Part 2: ADA ew + MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/122 (0.00%)      2/123 (1.63%)      0/15 (0.00%)      3/95 (3.16%)      1/54 (1.85%)      3/63 (4.76%)    
Gastrointestinal disorders             
GASTRIC MUCOSA ERYTHEMA  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 1/63 (1.59%)  1
GASTRITIS  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 1/63 (1.59%)  1
Infections and infestations             
DIVERTICULITIS  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 1/95 (1.05%)  1 0/54 (0.00%)  0 0/63 (0.00%)  0
PNEUMONIA  1  0/122 (0.00%)  0 1/123 (0.81%)  1 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 0/63 (0.00%)  0
SUBCUTANEOUS ABSCESS  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 1/95 (1.05%)  1 0/54 (0.00%)  0 0/63 (0.00%)  0
Injury, poisoning and procedural complications             
ANKLE FRACTURE  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 1/95 (1.05%)  1 0/54 (0.00%)  0 0/63 (0.00%)  0
LIGAMENT SPRAIN  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 1/95 (1.05%)  1 0/54 (0.00%)  0 0/63 (0.00%)  0
LUMBAR VERTEBRAL FRACTURE  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 1/54 (1.85%)  1 0/63 (0.00%)  0
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 1/95 (1.05%)  2 0/54 (0.00%)  0 0/63 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 1/95 (1.05%)  2 0/54 (0.00%)  0 0/63 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
BASAL CELL CARCINOMA  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 1/63 (1.59%)  1
Nervous system disorders             
SCIATICA  1  0/122 (0.00%)  0 1/123 (0.81%)  1 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 0/63 (0.00%)  0
Renal and urinary disorders             
URETEROLITHIASIS  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 1/54 (1.85%)  1 0/63 (0.00%)  0
Reproductive system and breast disorders             
UTERINE POLYP  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders             
ASTHMA  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 1/63 (1.59%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: MTX Escalated Dose Part 1: ADA + MTX Part 2: MTX Escalated Dose Part 2: ADA + MTX Escalated Dose Part 2: ADA Part 2: ADA ew + MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/122 (26.23%)      24/123 (19.51%)      5/15 (33.33%)      25/95 (26.32%)      5/54 (9.26%)      20/63 (31.75%)    
Gastrointestinal disorders             
NAUSEA  1  11/122 (9.02%)  13 5/123 (4.07%)  5 1/15 (6.67%)  1 4/95 (4.21%)  4 0/54 (0.00%)  0 1/63 (1.59%)  1
General disorders             
DRUG INTOLERANCE  1  8/122 (6.56%)  12 0/123 (0.00%)  0 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 0/63 (0.00%)  0
Hepatobiliary disorders             
HEPATITIS  1  0/122 (0.00%)  0 0/123 (0.00%)  0 1/15 (6.67%)  1 0/95 (0.00%)  0 0/54 (0.00%)  0 0/63 (0.00%)  0
Infections and infestations             
BRONCHITIS  1  0/122 (0.00%)  0 0/123 (0.00%)  0 1/15 (6.67%)  1 1/95 (1.05%)  1 0/54 (0.00%)  0 0/63 (0.00%)  0
NASOPHARYNGITIS  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 6/95 (6.32%)  6 1/54 (1.85%)  1 2/63 (3.17%)  2
PNEUMONIA  1  0/122 (0.00%)  0 0/123 (0.00%)  0 1/15 (6.67%)  1 0/95 (0.00%)  0 0/54 (0.00%)  0 1/63 (1.59%)  1
UPPER RESPIRATORY TRACT INFECTION  1  11/122 (9.02%)  11 10/123 (8.13%)  10 0/15 (0.00%)  0 13/95 (13.68%)  13 2/54 (3.70%)  2 9/63 (14.29%)  11
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  0/122 (0.00%)  0 0/123 (0.00%)  0 1/15 (6.67%)  1 2/95 (2.11%)  4 1/54 (1.85%)  2 3/63 (4.76%)  5
TRANSAMINASES INCREASED  1  0/122 (0.00%)  0 0/123 (0.00%)  0 1/15 (6.67%)  1 0/95 (0.00%)  0 0/54 (0.00%)  0 1/63 (1.59%)  1
Musculoskeletal and connective tissue disorders             
BACK PAIN  1  0/122 (0.00%)  0 0/123 (0.00%)  0 0/15 (0.00%)  0 1/95 (1.05%)  1 1/54 (1.85%)  1 4/63 (6.35%)  4
PSORIATIC ARTHROPATHY  1  0/122 (0.00%)  0 0/123 (0.00%)  0 1/15 (6.67%)  1 0/95 (0.00%)  0 0/54 (0.00%)  0 4/63 (6.35%)  4
Nervous system disorders             
HEADACHE  1  2/122 (1.64%)  3 10/123 (8.13%)  10 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 0/63 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
COUGH  1  1/122 (0.82%)  1 7/123 (5.69%)  8 0/15 (0.00%)  0 0/95 (0.00%)  0 0/54 (0.00%)  0 0/63 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02814175    
Other Study ID Numbers: M14-496
2016-000191-21 ( EudraCT Number )
First Submitted: June 21, 2016
First Posted: June 27, 2016
Results First Submitted: September 15, 2020
Results First Posted: November 23, 2020
Last Update Posted: November 23, 2020