A Study to Evaluate the Pharmacokinetics, Efficacy and Sa... | NCT02277444

ID	Type	Description	Link
CNTO148JIA3003	Other Identifier	Janssen Research & Development, LLC
2015-004804-47	EudraCT Number

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Golimumab + Methotrexate	Experimental	Participants will receive 80 milligram per meter square (mg/m^2) as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks thereafter up to Week 244, along with commercial methotrexate (MTX) weekly through Week 28 at the same Body Surface Area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at the time of study entry. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m^2 every 8 weeks after completion of the Week 252 assessments.	Drug: Golimumab Drug: Methotrexate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Golimumab	Drug	Golimumab 80 mg/m^2 IV infusion at Weeks 0, 4, and every 8 weeks through Week 244. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m^2 every 8 weeks after completion of the Week 252 assessments.

Measure	Description	Time Frame
Serum Trough Concentration (C-trough) of Golimumab	Serum golimumab trough concentration at Week 28 was reported.	Week 28
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28	AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).	Week 28

Measure	Description	Time Frame
Serum Trough Concentration (C-trough) at Week 52	Serum golimumab trough concentration at Week 52 was reported.	Week 52
Baysesian Area Under Curve at Steady State (AUCss) at Week 52	AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis must be made per Juvenile Idiopathic Arthritis (JIA) International League of Associations for Rheumatology (ILAR) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday
Failure or inadequate response to at least a 2 month course of methotrexate (MTX) before screening
Participants must have greater than or equal to (>=) 5 joints with active arthritis at screening and at Week 0 as defined by American College of Rheumatology (ACR) criteria (that is, a joint with either swelling, or in the absence of swelling, limited range of motion associated with pain on motion or tenderness)
Participants must have a screening C-reactive protein (CRP) of >=0.1 milligram (mg)/deciliter (dL) with the exception of approximately 30 percent (%) of the study population
Participants must have active polyarticular juvenile idiopathic arthritis (pJIA) despite current use of oral, intramuscular, or subcutaneous MTX for >=2 months before screening. For participants with body surface area (BSA) less than (<)1.67 meter square (m^2), the MTX dose must be between 10 to 30 milligram per meter square (mg/m^2) per week and stable for >=4 weeks before screening. For participants with BSA >=1.67 m^2, the MTX dose must be a minimum of 15 mg/week and must be stable for >=4 weeks before screening. In situations where there is documented intolerance of doses greater than (>)10 mg/m^2 weekly (for participants with BSA <1.67 m^2) or >=15 mg/week (for participants with BSA >=1.67 m^2); or where documented country or site regulations prohibit use of >=15 mg of MTX per week in participants with BSA >=1.67 m^2, participants may be entered into the trial on a lower dose of MTX

Exclusion Criteria:

Participant has initiated disease-modifying antirheumatic drugs (DMARDs) and/or immunosuppressive therapy within 4 weeks prior to first study agent administration
Participant has been treated with intra-articular, intramuscular or intravenous corticosteroids (including intramuscular corticotropin) during the 4 weeks before first study agent administration
Participant has been treated with any therapeutic agent targeted at reducing Interleukin (IL)-12 or IL 23, including but not limited to ustekinumab and ABT-874, within 3 months before first study agent administration
Participant has been treated with natalizumab, efalizumab, or therapeutic agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents
Participant has been treated with alefacept within 3 months before first study agent administration
If a participant has been previously treated with an anti-tumor necrosis factor alpha (TNF alpha) agent, the reason for discontinuation of the anti-TNF alpha agent cannot have been a severe or serious adverse event consistent with the class of anti-TNF alpha agents

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
36171515	Derived	Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.
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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Golimumab	Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square [m^2], or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m^2 IV golimumab q8w from Week 252 to Week 420.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 17, 2020	Oct 9, 2025

Arm/Group Information

ID	Title	Description
BG000	Golimumab	Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square [m^2], or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m^2 IV golimumab q8w from Week 252 to Week 420.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Serum Trough Concentration (C-trough) of Golimumab

Serum golimumab trough concentration at Week 28 was reported.

The pharmacokinetic (PK) analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

micrograms per milliliter (mcg/mL)

Week 28

ID	Title	Description
OG000	Golimumab	Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square [m^2], or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m^2 IV golimumab q8w from Week 252 to Week 420.

Units	Counts
Participants	OG00087

Title

Denominators

Categories

Title	Measurements
	OG0000.50± 0.427

Primary

Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28

AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.

Posted

Median

Full Range

micrograms*day/milliliter (mcg*day/mL)

Week 28

ID	Title	Description
OG000	Golimumab	Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square [m^2], or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m^2 IV golimumab q8w from Week 252 to Week 420.

Secondary

Serum Trough Concentration (C-trough) at Week 52

Serum golimumab trough concentration at Week 52 was reported.

The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

mcg/mL

Week 52

ID	Title	Description
OG000	Golimumab	Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square [m^2], or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m^2 IV golimumab q8w from Week 252 to Week 420.

Secondary

Baysesian Area Under Curve at Steady State (AUCss) at Week 52

AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.

Posted

Median

Full Range

mcg*day/mL

Week 52

ID	Title	Description
OG000	Golimumab	Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square [m^2], or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m^2 IV golimumab q8w from Week 252 to Week 420.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	Participants received 80 milligrams per meter square (mg/m^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square [m^2], or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase.	1	127	9	127	74	127
EG001	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	Participants who completed Week 52 and entered into the LTE phase, continued to receive 80 mg/m^2 intravenous golimumab every 8 weeks through Week 244. Those who chose not to enter LTE completed an additional 8-week safety follow-up visit after their final administration of the study agent. All participants who completed Week 244 were monitored for safety through Week 252.	1	127	18	127	57	127
EG002	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	Participants who met the inclusion criteria entered the ETP and continued receiving 80 mg/m^2 intravenous golimumab every 8 weeks from Week 252 to Week 420.	0	32	3	32	8	32

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myopericarditis	Cardiac disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Glaucoma	Eye disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Retinal Detachment	Eye disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Calcinosis	General disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0021 affected32 at risk
Drug Intolerance	General disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Ocular Implant Exposure	General disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0010 affected127 at risk EG0021 affected32 at risk
Temperature Regulation Disorder	General disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Hypersensitivity	Immune system disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Appendicitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0010 affected127 at risk EG0021 affected32 at risk
Cellulitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Disseminated Tuberculosis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Escherichia Infection	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Furuncle	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Herpes Zoster Disseminated	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected127 at risk EG0020 affected32 at risk
Infective Exacerbation of Bronchiectasis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected127 at risk EG0020 affected32 at risk
Pneumonia	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Pneumonia Streptococcal	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected127 at risk EG0020 affected32 at risk
Sepsis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Septic Shock	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Tonsillitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Varicella	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Cutaneous T-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected127 at risk EG0020 affected32 at risk
Generalised Anxiety Disorder	Psychiatric disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Major Depression	Psychiatric disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected127 at risk EG0020 affected32 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG0010 affected127 at risk EG0020 affected32 at risk
Cyanosis	Vascular disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0000 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG0008 affected127 at risk EG0012 affected127 at risk EG0020 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG00011 affected127 at risk EG0017 affected127 at risk EG0020 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 21.1	Non-systematic Assessment	EG00010 affected127 at risk EG0015 affected127 at risk EG0020 affected32 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0006 affected127 at risk EG00112 affected127 at risk EG0021 affected32 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG00022 affected127 at risk EG00116 affected127 at risk EG0022 affected32 at risk
Pharyngitis	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0004 affected127 at risk EG0018 affected127 at risk EG0020 affected32 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG00028 affected127 at risk EG00119 affected127 at risk EG0021 affected32 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 21.1	Non-systematic Assessment	EG0001 affected127 at risk EG00112 affected127 at risk EG0020 affected32 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 21.1	Non-systematic Assessment	EG0007 affected127 at risk EG0011 affected127 at risk EG0020 affected32 at risk
Arthritis	Nervous system disorders	MedDRA Version 27.0	Non-systematic Assessment	EG0004 affected127 at risk EG0017 affected127 at risk EG0023 affected32 at risk
Juvenile Idiopathic Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Non-systematic Assessment	EG00014 affected127 at risk EG00118 affected127 at risk EG0022 affected32 at risk
Headache	Nervous system disorders	MedDRA Version 21.1	Non-systematic Assessment	EG00014 affected127 at risk EG0016 affected127 at risk EG0021 affected32 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		San Diego	California		United States

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds