NCT02196701 (CLEAR) is a Phase 3 clinical trial of Adalimumab in Psoriasis, sponsored by AbbVie.

Who is sponsoring NCT02196701?

NCT02196701 is sponsored by AbbVie.

What drugs are being tested in NCT02196701?

Interventions in NCT02196701: Adalimumab, Methotrexate.

Is NCT02196701 still recruiting?

NCT02196701 is currently completed. Last updated 19 March 2018.

Are results published for NCT02196701?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-19 · How we verify

NCT02196701: CLEAR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Completed Phase 3 Results posted Last updated 19 March 2018

What this trial tests

Phase 3 trial testing Adalimumab in Psoriasis in 46 participants. Completed in 17 March 2017.

Timeline

5 August 2014

Primary endpoint
17 March 2017

17 March 2017

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	5 August 2014
Primary completion	17 March 2017
Estimated completion	17 March 2017

Drugs / interventions tested

Adalimumab (ADALIMUMAB) — full drug profile →
Methotrexate — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 99, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment Primary · Week 16

Study investigators were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	33.3	0.0 – 71.1
Secondary Sub-optimal Responders - ADA + MTX	52.5	37.0 – 68.0
Adalimumab + Methotrexate	50.0	35.6 – 64.4

Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment Primary · Week 16

Participants were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	52.5	37.0 – 68.0
Adalimumab + Methotrexate	47.8	33.4 – 62.3

Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time Secondary · Baseline, week 8 and week 24

Study investigators were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Baseline

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	0	0.0 – 0.0
Secondary Sub-optimal Responders - ADA + MTX	0	0.0 – 0.0
Adalimumab + Methotrexate	0	0.0 – 0.0

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	50.0	10.0 – 90.0
Secondary Sub-optimal Responders - ADA + MTX	42.5	27.2 – 57.8
Adalimumab + Methotrexate	43.5	29.2 – 57.8

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	33.3	0.0 – 71.1
Secondary Sub-optimal Responders - ADA + MTX	60.0	44.8 – 75.2
Adalimumab + Methotrexate	56.5	42.2 – 70.8

Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time Secondary · Baseline, week 8 and week 24

Participants were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Baseline

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	0	0.0 – 0.0
Secondary Sub-optimal Responders - ADA + MTX	17.5	5.7 – 29.3
Adalimumab + Methotrexate	15.2	4.8 – 25.6

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	52.5	37.0 – 68.0
Adalimumab + Methotrexate	47.8	33.4 – 62.3

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	60.0	44.8 – 75.2
Adalimumab + Methotrexate	54.3	40.0 – 68.7

Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Secondary · Baseline, weeks 8, 16, and 24

Baseline

Group	Value	95% CI
Adalimumab + Methotrexate	0
Adalimumab + Methotrexate	0
Adalimumab + Methotrexate	8
Adalimumab + Methotrexate	31

Week 8

Group	Value	95% CI
Adalimumab + Methotrexate	6
Adalimumab + Methotrexate	14
Adalimumab + Methotrexate	15
Adalimumab + Methotrexate	9

Week 16

Group	Value	95% CI
Adalimumab + Methotrexate	8
Adalimumab + Methotrexate	15
Adalimumab + Methotrexate	10
Adalimumab + Methotrexate	8

Week 24

Group	Value	95% CI
Adalimumab + Methotrexate	11
Adalimumab + Methotrexate	15
Adalimumab + Methotrexate	7
Adalimumab + Methotrexate	6

Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Secondary · Baseline, weeks 8, 16, and 24

Baseline

Group	Value	95% CI
Adalimumab + Methotrexate	5
Adalimumab + Methotrexate	2
Adalimumab + Methotrexate	15
Adalimumab + Methotrexate	17

Week 8

Group	Value	95% CI
Adalimumab + Methotrexate	10
Adalimumab + Methotrexate	12
Adalimumab + Methotrexate	14
Adalimumab + Methotrexate	7

Week 16

Group	Value	95% CI
Adalimumab + Methotrexate	7
Adalimumab + Methotrexate	15
Adalimumab + Methotrexate	13
Adalimumab + Methotrexate	6

Week 24

Group	Value	95% CI
Adalimumab + Methotrexate	10
Adalimumab + Methotrexate	15
Adalimumab + Methotrexate	7
Adalimumab + Methotrexate	6

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time Secondary · Baseline and Weeks 8, 16, and 24

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	50.0	10.0 – 90.0
Secondary Sub-optimal Responders - ADA + MTX	42.5	27.2 – 57.8
Adalimumab + Methotrexate	43.5	29.2 – 57.8

Week 16

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	50.0	10.0 – 90.0
Secondary Sub-optimal Responders - ADA + MTX	62.5	47.5 – 77.5
Adalimumab + Methotrexate	60.9	46.8 – 75.0

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	66.7	28.9 – 100.0
Secondary Sub-optimal Responders - ADA + MTX	65.0	50.2 – 79.8
Adalimumab + Methotrexate	65.2	51.5 – 79.0

Percentage of Participants Who Achieved a PASI 75 Response Over Time Secondary · Baseline and Weeks 8, 16, and 24

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	33.3	0.0 – 71.1
Secondary Sub-optimal Responders - ADA + MTX	27.5	13.7 – 41.3
Adalimumab + Methotrexate	28.3	15.2 – 41.3

Week 16

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	42.5	27.2 – 57.8
Adalimumab + Methotrexate	39.1	25.0 – 53.2

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	42.5	27.2 – 57.8
Adalimumab + Methotrexate	39.1	25.0 – 53.2

Percentage of Participants Who Achieved a PASI 90 Response Over Time Secondary · Baseline and Weeks 8, 16, and 24

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	12.5	2.3 – 22.7
Adalimumab + Methotrexate	13.0	3.3 – 22.8

Week 16

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	15.0	3.9 – 26.1
Adalimumab + Methotrexate	15.2	4.8 – 25.6

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	30.0	15.8 – 44.2
Adalimumab + Methotrexate	28.3	15.2 – 41.3

Percentage of Participants Who Achieved a PASI 100 Response Over Time Secondary · Baseline and Weeks 8, 16, and 24

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	12.5	2.3 – 22.7
Adalimumab + Methotrexate	13.0	3.3 – 22.8

Week 16

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	10.0	0.7 – 19.3
Adalimumab + Methotrexate	10.9	1.9 – 19.9

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	16.7	0.0 – 46.5
Secondary Sub-optimal Responders - ADA + MTX	27.5	13.7 – 41.3
Adalimumab + Methotrexate	26.1	13.4 – 38.8

Change From Baseline in PASI Score Over Time Secondary · Baseline and weeks 8, 16, and 24

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	-4.6	± 2.07
Secondary Sub-optimal Responders - ADA + MTX	-4.6	± 0.65
Adalimumab + Methotrexate	-4.6	± 0.61

Week 16

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	-4.5	± 1.31
Secondary Sub-optimal Responders - ADA + MTX	-6.2	± 0.59
Adalimumab + Methotrexate	-5.9	± 0.53

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	-3.1	± 3.17
Secondary Sub-optimal Responders - ADA + MTX	-6.3	± 0.68
Adalimumab + Methotrexate	-5.9	± 0.74

Percent Change From Baseline in PASI Score Secondary · Baseline and weeks 8, 16, and 24

Week 8

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	-51.6	± 16.23
Secondary Sub-optimal Responders - ADA + MTX	-43.7	± 6.11
Adalimumab + Methotrexate	-44.8	± 5.64

Week 16

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	-45.6	± 15.15
Secondary Sub-optimal Responders - ADA + MTX	-59.2	± 5.06
Adalimumab + Methotrexate	-57.3	± 4.74

Week 24

Group	Value	95% CI
Primary Sub-optimal Responders - ADA + MTX	-17.4	± 45.65
Secondary Sub-optimal Responders - ADA + MTX	-63.7	± 5.78
Adalimumab + Methotrexate	-58.1	± 8.01

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adalimumab + Methotrexate

Serious: 1/46 (2%)

Deaths: 0/46

Serious adverse events (4 terms)

Reaction	System	Adalimumab + Methotrexate
Cardiac arrest	Cardiac disorders	—
Generalised tonic-clonic seizure	Nervous system disorders	—
Loss of consciousness	Nervous system disorders	—
Hypercapnia	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (45 terms — click to expand)

Reaction	System	Adalimumab + Methotrexate
Nasopharyngitis	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Nausea	Gastrointestinal disorders	—
Bronchitis	Infections and infestations	—
Fatigue	General disorders	—
Gastroenteritis	Infections and infestations	—
Pneumonia	Infections and infestations	—
Sinusitis	Infections and infestations	—
Tooth abscess	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Alanine aminotransferase increased	Investigations	—
Gout	Metabolism and nutrition disorders	—
Insomnia	Psychiatric disorders	—
Acne	Skin and subcutaneous tissue disorders	—
Vision blurred	Eye disorders	—
Abdominal discomfort	Gastrointestinal disorders	—
Abdominal distension	Gastrointestinal disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Chest pain	General disorders	—
Cyst	General disorders	—
Vessel puncture site bruise	General disorders	—
Beta haemolytic streptococcal infection	Infections and infestations	—
Folliculitis	Infections and infestations	—
Pharyngitis streptococcal	Infections and infestations	—
Streptococcal bacteraemia	Infections and infestations	—
Tooth infection	Infections and infestations	—
Lower limb fracture	Injury, poisoning and procedural complications	—
Seroma	Injury, poisoning and procedural complications	—
Wrist fracture	Injury, poisoning and procedural complications	—
Aspartate aminotransferase increased	Investigations	—
Liver function test increased	Investigations	—
Hyperlipidaemia	Metabolism and nutrition disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Polymyalgia rheumatica	Metabolism and nutrition disorders	—
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	—
Neuralgia	Nervous system disorders	—
Paraesthesia	Nervous system disorders	—
Mood altered	Psychiatric disorders	—
Sleep disorder	Psychiatric disorders	—

Most-reported serious reactions: Cardiac arrest, Generalised tonic-clonic seizure, Loss of consciousness, Hypercapnia.

Data from ClinicalTrials.gov NCT02196701 adverse events section.

Sponsor's own description

The purpose of this study is to determine the safety and efficacy of the use of the combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in suboptimal responders to ADA monotherapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02196701 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 19 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02196701.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02196701: CLEAR

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Adalimumab

Other recruiting trials for Psoriasis

Other AbbVie trials

Verify against primary sources