NCT02925338 (ReFLECT) is a clinical trial of QOL questionaire in Crohn Disease, sponsored by Pfizer.

Who is sponsoring NCT02925338?

NCT02925338 is sponsored by Pfizer.

What drugs are being tested in NCT02925338?

Interventions in NCT02925338: QOL questionaire.

What condition does NCT02925338 study?

NCT02925338 studies Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis.

Is NCT02925338 still recruiting?

NCT02925338 is currently completed. Last updated 25 January 2023.

Are results published for NCT02925338?

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

Last reviewed 2023-01-25 · How we verify

NCT02925338: ReFLECT

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

National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life

Completed Results posted Last updated 25 January 2023

What this trial tests

trial testing QOL questionaire in Crohn Disease in 1,431 participants. Completed in 12 April 2021.

Timeline

19 October 2016

Primary endpoint
12 April 2021

12 April 2021

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,431
Start date	19 October 2016
Primary completion	12 April 2021
Estimated completion	12 April 2021
Sites	67 locations across France

Drugs / interventions tested

QOL questionaire

Conditions studied

Crohn Disease — all drugs for Crohn Disease →
Ulcerative Colitis — all drugs for Ulcerative Colitis →
Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →

Sponsor

Pfizer — full company profile →

Who can join

6 and older, any sex, with Crohn Disease or Ulcerative Colitis. 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 Without Treatment Failure During 2-Years of Observation Primary · 2 years post inclusion in the study

Treatment failure was defined as permanent discontinuation of the Inflectra treatment due to intolerance and/or permanent discontinuation of treatment due to absence of response according to the physician's assessment, or death of the participant related to Inflectra. In this outcome measure percentage of participants without treatment failure and whose data were missing are reported.

Without Treatment Failure

Group	Value	95% CI
Crohn's Disease (CD)	59.2	55.1 – 63.4
Ulcerative Colitis (UC)	53.5	47.0 – 59.9
Rheumatoid Arthritis (RA)	53.5	45.3 – 61.7
Ankylosing Spondylitis (SpA)	61.1	56.4 – 65.8
Psoriatic Arthritis (PA)	64.6	55.0 – 74.2

Missing Data

Group	Value	95% CI
Crohn's Disease (CD)	19.2	15.9 – 22.5
Ulcerative Colitis (UC)	21.3	16.0 – 26.6
Rheumatoid Arthritis (RA)	7.7	3.3 – 12.1
Ankylosing Spondylitis (SpA)	14.4	11.0 – 17.7
Psoriatic Arthritis (PA)	9.4	3.5 – 15.2

Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy Primary · Data collected and recorded at study inclusion visit

Pre-treatment assessment was a check-list with the set of measures determined by the physician to check the eligibility of a participant before initiation of treatment. Physician recorded as "Yes" if a participant was eligible for initiation of treatment and "No" if a participant was not eligible to initiate a treatment. In this outcome measure, number of participants whose pre-treatment assessment were performed prior to initiation of Inflectra are reported and whose data were missing are reported.

Had Pre-treatment Assessment

Group	Value	95% CI
Crohn's Disease (CD)	458
Ulcerative Colitis (UC)	177
Rheumatoid Arthritis (RA)	118
Ankylosing Spondylitis (SpA)	355
Psoriatic Arthritis (PA)	86

Missing Data

Group	Value	95% CI
Crohn's Disease (CD)	5
Ulcerative Colitis (UC)	4
Rheumatoid Arthritis (RA)	2
Ankylosing Spondylitis (SpA)	2
Psoriatic Arthritis (PA)	0

Time Between Diagnosis and Inclusion in Study Primary · Data collected and recorded at study inclusion visit

Group	Value	95% CI
Crohn's Disease (CD)	10.05	± 9.51
Ulcerative Colitis (UC)	8.77	± 8.56
Rheumatoid Arthritis (RA)	15.18	± 10.13
Ankylosing Spondylitis (SpA)	13.58	± 10.26
Psoriatic Arthritis (PA)	11.50	± 8.42

Time Between Diagnosis and the First Inflectra Infusion Primary · Data collected and recorded at study inclusion visit

Group	Value	95% CI
Crohn's Disease (CD)	9.37	± 9.67
Ulcerative Colitis (UC)	8.22	± 8.66
Rheumatoid Arthritis (RA)	14.39	± 10.11
Ankylosing Spondylitis (SpA)	12.80	± 10.29
Psoriatic Arthritis (PA)	10.78	± 8.42

Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study Primary · Data collected and recorded at study inclusion visit

Type of biotherapies received by participants before inclusion in the study were: anti-TNF alpha (remicade/ adalimumab/ golimumab / etanercept/ rituximab); anti-integrin (vedolizumab); immunosuppressant (abatacept); interleukin inhibitor (anakinra / tocilizumab); anti interleukin (IL) 12 and anti IL-23 (ustekinumab); and other. In this outcome measure number of participants who received biotherapies other than Inflectra and whose data were missing are reported.

Received Biotherapy

Group	Value	95% CI
Crohn's Disease (CD)	347
Ulcerative Colitis (UC)	146
Rheumatoid Arthritis (RA)	116
Ankylosing Spondylitis (SpA)	344
Psoriatic Arthritis (PA)	81

Missing Data

Group	Value	95% CI
Crohn's Disease (CD)	4
Ulcerative Colitis (UC)	2
Rheumatoid Arthritis (RA)	0
Ankylosing Spondylitis (SpA)	0
Psoriatic Arthritis (PA)	0

Number of Participants With Reasons for Discontinuation of Previous Biotherapy Primary · Data collected and recorded at study inclusion visit

Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure, number of participants who discontinued previous biotherapy are reported according to reason of discontinuations.

Group	Value	95% CI
Crohn's Disease (CD)	13
Ulcerative Colitis (UC)	5
Rheumatoid Arthritis (RA)	5
Ankylosing Spondylitis (SpA)	29
Psoriatic Arthritis (PA)	6
Crohn's Disease (CD)	80
Ulcerative Colitis (UC)	35
Rheumatoid Arthritis (RA)	19
Ankylosing Spondylitis (SpA)	52
Psoriatic Arthritis (PA)	14
Crohn's Disease (CD)	25
Ulcerative Colitis (UC)	40
Rheumatoid Arthritis (RA)	16
Ankylosing Spondylitis (SpA)	49
Psoriatic Arthritis (PA)	10
Crohn's Disease (CD)	42
Ulcerative Colitis (UC)	5
Rheumatoid Arthritis (RA)	9
Ankylosing Spondylitis (SpA)	23
Psoriatic Arthritis (PA)	9

Duration of Previous Biotherapies Primary · Data collected and recorded at study inclusion visit

Group	Value	95% CI
Crohn's Disease (CD)	51.3	± 43.1
Ulcerative Colitis (UC)	33.2	± 38.2
Rheumatoid Arthritis (RA)	81.0	± 55.8
Ankylosing Spondylitis (SpA)	73.1	± 51.2
Psoriatic Arthritis (PA)	70.4	± 60.7

Mean of Number of Doses Administered in Previous Biotherapy Primary · Data collected and recorded at study inclusion visit

Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure mean of number of doses administered in previous biotherapy is reported.

Group	Value	95% CI
Crohn's Disease (CD)	38.2	± 48.1
Ulcerative Colitis (UC)	26.5	± 24.5
Rheumatoid Arthritis (RA)	33.5	± 30.1
Ankylosing Spondylitis (SpA)	39.2	± 55.6
Psoriatic Arthritis (PA)	24.3	± 26.6

Last Dosage Administered of a Previous Biotherapy Primary · Data collected and recorded at study inclusion visit

Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure mean of last dosage (in units) of previous biotherapy administered dose is reported.

Group	Value	95% CI
Crohn's Disease (CD)	104.4	± 193.3
Ulcerative Colitis (UC)	86.8	± 127.2
Rheumatoid Arthritis (RA)	204.8	± 255.5
Ankylosing Spondylitis (SpA)	216.7	± 218.0
Psoriatic Arthritis (PA)	238.4	± 227.9

Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Primary · Data collected and recorded at study inclusion visit

Following concomitant treatments were received by participants before initiation of Inflectra: 1) Corticosteroids, 2) Salicylates, and 3) Azathioprine/6-MP, Methotrexate, and Cyclosporine.

Corticosteroids

Group	Value	95% CI
Crohn's Disease (CD)	5
Ulcerative Colitis (UC)	1
Rheumatoid Arthritis (RA)	0
Ankylosing Spondylitis (SpA)	0
Psoriatic Arthritis (PA)	0
Crohn's Disease (CD)	440
Ulcerative Colitis (UC)	162
Rheumatoid Arthritis (RA)	83
Ankylosing Spondylitis (SpA)	373
Psoriatic Arthritis (PA)	82
Crohn's Disease (CD)	102
Ulcerative Colitis (UC)	67
Rheumatoid Arthritis (RA)	59
Ankylosing Spondylitis (SpA)	38
Psoriatic Arthritis (PA)	14

Salicylates

Group	Value	95% CI
Crohn's Disease (CD)	6
Ulcerative Colitis (UC)	1
Rheumatoid Arthritis (RA)	0
Ankylosing Spondylitis (SpA)	1
Psoriatic Arthritis (PA)	0
Crohn's Disease (CD)	339
Ulcerative Colitis (UC)	70
Rheumatoid Arthritis (RA)	131
Ankylosing Spondylitis (SpA)	359
Psoriatic Arthritis (PA)	90
Crohn's Disease (CD)	202
Ulcerative Colitis (UC)	159
Rheumatoid Arthritis (RA)	11
Ankylosing Spondylitis (SpA)	51
Psoriatic Arthritis (PA)	6

Azathioprine/6-MP; Methotrexate; Cyclosporine

Group	Value	95% CI
Crohn's Disease (CD)	5
Ulcerative Colitis (UC)	1
Rheumatoid Arthritis (RA)	0
Ankylosing Spondylitis (SpA)	0
Psoriatic Arthritis (PA)	0
Crohn's Disease (CD)	144
Ulcerative Colitis (UC)	62
Rheumatoid Arthritis (RA)	17
Ankylosing Spondylitis (SpA)	224
Psoriatic Arthritis (PA)	22
Crohn's Disease (CD)	398
Ulcerative Colitis (UC)	167
Rheumatoid Arthritis (RA)	125
Ankylosing Spondylitis (SpA)	187
Psoriatic Arthritis (PA)	74

Physician Global Assessment (PGA) of Disease for RA, SpA and PA Secondary · 24 months

PGA was evaluated in participants with RA, SpA and PA on a 0 to 10 centimeter (cm) visual analog scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible. Higher scores indicated worse condition.

Group	Value	95% CI
Rheumatoid Arthritis (RA)	3.5	± 2.6
Ankylosing Spondylitis (SpA)	3.2	± 2.4
Psoriatic Arthritis (PA)	3.2	± 2.3

Mean Administered Dose of Inflectra (in mg) Secondary · Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit

Mean dose (in milligrams \[mg\]) administered was sum of dose of all infusions administered divided by total number of doses administered.

Inclusion to Month 6

Group	Value	95% CI
Crohn's Disease (CD)	451.0	± 184.5
Ulcerative Colitis (UC)	493.9	± 202.1
Rheumatoid Arthritis (RA)	313.7	± 125.4
Ankylosing Spondylitis (SpA)	406.9	± 113.4
Psoriatic Arthritis (PA)	440.8	± 142.5

Month 6 to Month 12

Group	Value	95% CI
Crohn's Disease (CD)	473.4	± 195.6
Ulcerative Colitis (UC)	534.0	± 213.2
Rheumatoid Arthritis (RA)	313.4	± 127.3
Ankylosing Spondylitis (SpA)	411.3	± 123.0
Psoriatic Arthritis (PA)	441.2	± 152.2

Month 12 to Month 18

Group	Value	95% CI
Crohn's Disease (CD)	503.1	± 211.7
Ulcerative Colitis (UC)	520.8	± 212.7
Rheumatoid Arthritis (RA)	313.1	± 121.7
Ankylosing Spondylitis (SpA)	414.8	± 120.6
Psoriatic Arthritis (PA)	437.7	± 155.1

Month 18 to Month 24

Group	Value	95% CI
Crohn's Disease (CD)	515.6	± 223.6
Ulcerative Colitis (UC)	533.6	± 218.5
Rheumatoid Arthritis (RA)	317.5	± 109.2
Ankylosing Spondylitis (SpA)	417.3	± 127.0
Psoriatic Arthritis (PA)	433.7	± 155.6

Adverse events — posted to ClinicalTrials.gov

Time frame: During 2 years post inclusion in the study (24 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Crohn's Disease (CD)

Serious: 73/547 (13%)

Deaths: 1/547

Ulcerative Colitis (UC)

Serious: 28/230 (12%)

Deaths: 2/230

Rheumatoid Arthritis (RA)

Serious: 20/142 (14%)

Deaths: 1/142

Ankylosing Spondylitis (SpA)

Serious: 47/411 (11%)

Deaths: 0/411

Psoriatic Arthritis (PA)

Serious: 10/96 (10%)

Deaths: 0/96

Serious adverse events (188 terms)

Reaction	System	Crohn's Disease (CD)	Ulcerative Colitis (UC)	Rheumatoid Arthritis (RA)	Ankylosing Spondylitis (SpA)	Psoriatic Arthritis (PA)
ILEOCOLOSTOMY	Surgical and medical procedures	—	—	—	—	—
CROHN'S DISEASE	Gastrointestinal disorders	—	—	—	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—	—	—	—
COLITIS ULCERATIVE	Gastrointestinal disorders	—	—	—	—	—
ANAL ABSCESS	Infections and infestations	—	—	—	—	—
COLITIS	Gastrointestinal disorders	—	—	—	—	—
ILEAL STENOSIS	Gastrointestinal disorders	—	—	—	—	—
PERITONITIS	Infections and infestations	—	—	—	—	—
LARGE INTESTINAL STENOSIS	Gastrointestinal disorders	—	—	—	—	—
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	—	—	—	—	—
HERPES ZOSTER	Infections and infestations	—	—	—	—	—
EVENTRATION REPAIR	Surgical and medical procedures	—	—	—	—	—
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
DRUG INEFFECTIVE	General disorders	—	—	—	—	—
FALL	Injury, poisoning and procedural complications	—	—	—	—	—
RADIUS FRACTURE	Injury, poisoning and procedural complications	—	—	—	—	—
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	—	—	—	—	—
SCIATICA	Nervous system disorders	—	—	—	—	—
CARDIAC FAILURE	Cardiac disorders	—	—	—	—	—
CARDIAC FLUTTER	Cardiac disorders	—	—	—	—	—
PREGNANCY	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—
RENAL COLIC	Renal and urinary disorders	—	—	—	—	—
DEPRESSION	Psychiatric disorders	—	—	—	—	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—	—	—	—	—
ABDOMINAL RIGIDITY	Gastrointestinal disorders	—	—	—	—	—

Other adverse events (549 terms — click to expand)

Reaction	System	Crohn's Disease (CD)	Ulcerative Colitis (UC)	Rheumatoid Arthritis (RA)	Ankylosing Spondylitis (SpA)	Psoriatic Arthritis (PA)
BRONCHITIS	Infections and infestations	—	—	—	—	—
ASTHENIA	General disorders	—	—	—	—	—
NASOPHARYNGITIS	Infections and infestations	—	—	—	—	—
TONSILLITIS	Infections and infestations	—	—	—	—	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—	—	—	—	—
HEADACHE	Nervous system disorders	—	—	—	—	—
DRUG INEFFECTIVE	General disorders	—	—	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—	—	—
RHINITIS	Infections and infestations	—	—	—	—	—
CONJUNCTIVITIS	Infections and infestations	—	—	—	—	—
PSORIASIS	Skin and subcutaneous tissue disorders	—	—	—	—	—
SINUSITIS	Infections and infestations	—	—	—	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—	—	—	—
COUGH	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
PRURITUS	Skin and subcutaneous tissue disorders	—	—	—	—	—
HEPATOCELLULAR INJURY	Hepatobiliary disorders	—	—	—	—	—
GASTROENTERITIS	Infections and infestations	—	—	—	—	—
CROHN'S DISEASE	Gastrointestinal disorders	—	—	—	—	—
INFLUENZA LIKE ILLNESS	General disorders	—	—	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—	—	—
ECZEMA	Skin and subcutaneous tissue disorders	—	—	—	—	—
OVERDOSE	Injury, poisoning and procedural complications	—	—	—	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—	—	—	—
IRON DEFICIENCY	Metabolism and nutrition disorders	—	—	—	—	—
VERTIGO	Ear and labyrinth disorders	—	—	—	—	—
DRY SKIN	Skin and subcutaneous tissue disorders	—	—	—	—	—
PARAESTHESIA	Nervous system disorders	—	—	—	—	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—
PYREXIA	General disorders	—	—	—	—	—
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	—	—	—	—	—
RASH	Skin and subcutaneous tissue disorders	—	—	—	—	—
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	—	—	—	—	—
LIGAMENT SPRAIN	Injury, poisoning and procedural complications	—	—	—	—	—
RENAL COLIC	Renal and urinary disorders	—	—	—	—	—
TOOTH ABSCESS	Infections and infestations	—	—	—	—	—
INFECTION	Infections and infestations	—	—	—	—	—
TOOTH INFECTION	Infections and infestations	—	—	—	—	—
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—

Most-reported serious reactions: ILEOCOLOSTOMY, CROHN'S DISEASE, ABDOMINAL PAIN, COLITIS ULCERATIVE, ANAL ABSCESS, COLITIS, ILEAL STENOSIS, PERITONITIS.

Data from ClinicalTrials.gov NCT02925338 adverse events section.

Sponsor's own description

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT).
Marotte H, Cantagrel A, Coury F, Schaeverbeke T, et al · · 2025 · cited 1× · PMID 40720061 · DOI 10.1007/s12325-025-03304-6
Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study).
Laharie D, Bouhnik Y, Vuitton L, Biron A, et al · · 2024 · cited 1× · PMID 39448029 · DOI 10.1016/j.clinre.2024.102483

Verify or expand the search:

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Currently open trials in the same condition.

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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 NCT02925338 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 25 January 2023

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/NCT02925338.

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

NCT02925338: ReFLECT

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 (188 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Crohn Disease

Other Pfizer trials

Verify against primary sources