Dose-finding Study of GLPG0634 as add-on to Methotrexate... | NCT01888874

NCT01888874

ID	Type	Description	Link
2012-003635-31	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.	Drug: Placebo
GLPG0634 50 mg QD	Experimental	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.	Drug: GLPG0634
GLPG0634 100 mg QD	Experimental	Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	Drug: GLPG0634
GLPG0634 200 mg QD	Experimental	Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.	Drug: GLPG0634
GLPG0634 25 mg BID	Experimental	Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.

Name	Type	Description	Arm Group Labels	Other Names
GLPG0634	Drug	GLPG0634 capsules.	GLPG0634 100 mg BID GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12	The American College of Rheumatology (ACR) response is a measurement of improvement in multiple disease assessment criteria. The ACR20 response is defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used (ie, to impute a missing response, the participant was assumed to be a non-responder).	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving an ACR20 Response at Week 24	ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Galapagos Study Director	Lakefront Biotherapeutics NV	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology Associates of North Alabama, PC		Huntsville	Alabama		United States
Artho Care, Arthritis Care & Research P.C.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37747626	Derived	Balsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.
36205910

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.

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	May 27, 2014	Oct 26, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
BG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
BG002	GLPG0634 100 mg QD	Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
BG003	GLPG0634 200 mg QD	Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
BG004	GLPG0634 25 mg BID	Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
BG005	GLPG0634 50 mg BID	Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
BG006	GLPG0634 100 mg BID	Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
BG007	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00052(18 to 84) BG00152.8(20 to 77) BG00252.3(20 to 79) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00070 BG00169 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00037 BG00137 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Rheumatoid Arthritis (RA) duration

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG0008.21(0.5 to 36.5) BG0017.21(0.6 to 21.3) BG002

C-reactive protein (CRP) at Baseline

Mean

Full Range

milligram per liter (mg/L)

Title

Denominators

Categories

Title	Measurements
	BG00016.25(1 to 84.5) BG00127.71(1 to 158.7) BG002

Corrected tender joint count based on 68 joints (TJC68) at Baseline

68 joints were assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.

Mean

Full Range

joint count

Title

Denominators

Categories

Title	Measurements
	BG00024.984(8 to 60) BG001

Corrected swollen joint count based on 66 joints (SJC66) at Baseline

66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.

Mean

Full Range

joint count

Title

Denominators

Categories

Title	Measurements
	BG00016.13(6 to 48) BG001

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

Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12

The American College of Rheumatology (ACR) response is a measurement of improvement in multiple disease assessment criteria. The ACR20 response is defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used (ie, to impute a missing response, the participant was assumed to be a non-responder).

Intent-to-treat (ITT) population included all participants in the safety population who had post-randomization data for at least one efficacy parameter.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
OG002	GLPG0634 100 mg QD	Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
OG003	GLPG0634 200 mg QD	Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
OG004	GLPG0634 25 mg BID	Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
OG005	GLPG0634 50 mg BID	Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
OG006	GLPG0634 100 mg BID	Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.

Units	Counts
Participants	OG00086 OG00182 OG00285 OG003

Title

Denominators

Categories

Title	Measurements
	OG00044.2 OG00156.1 OG00263.5 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.	Regression, Logistic	P-value has been corrected for multiplicity according to Hommel's closed-testing method.	0.1236		Difference in percentage rates	11.9			2-Sided	95	-3.1	26.9					Superiority

Secondary

Percentage of Participants Achieving an ACR20 Response at Week 24

ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used.

ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
OG002	GLPG0634 100 mg QD

Secondary

Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24

ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Total HAQ-DI score 5. CRP. Non-responder imputation was used.

ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Number

percentage of participants

Weeks 1, 2, 4, 8, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
OG002

Secondary

Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24

ACR70 response: 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used.

ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Number

percentage of participants

Weeks 1, 2, 4, 8, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
OG002

Secondary

ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24

The ACR-N is the smallest percentage improvement in swollen and tender joints and the median of the remaining 5 core parameters, and is expected to be more sensitive to change than the ACR20, ACR50 or ACR70. It is a number varying between 0 and 100, with higher numbers indicating less severity of symptoms. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).

ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Mean

Standard Error

percentage of improvement

Weeks 1, 2, 4, 8, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.

Secondary

Percentage of Participants With Disease Activity Score 28 Joints Corrected for CRP (DAS28 (CRP)) European League Against Rheumatism (EULAR) Response at Weeks 1, 2, 4, 8, 12, and 24

DAS28 (CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None = Actual DAS28 (CRP) ≤ 3.2, > 3.2 to ≤ 5.1, or > 5.1 AND Improvement in DAS28 (CRP) from baseline ≤ 6.0 or > 0.6 to ≤ 1.2; Moderate = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2, Actual DAS28 (CRP) > 3.2 to ≤ 5.1 or > 5.1 AND Improvement in DAS28 (CRP) from baseline > 1.2, or Actual DAS28 (CRP) > 3.2 to ≤ 5.1 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2; Good = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 1.2. LOCF algorithm was used.

ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Number

percentage of participants

Weeks 1, 2, 4, 8, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.

Secondary

Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24

A participant's disease activity status can be defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and Patient Global Assessment of Disease Activity (cm) are all ≤ 1. Non-responder imputation was used.

ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Number

percentage of participants

Weeks 2, 4, 8, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
OG002	GLPG0634 100 mg QD	Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.

Secondary

Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24

The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), Physician's Global Assessment of Disease Activity (in cm), and CRP (mg/dL). The SDAI was categorized as follows:

• High disease activity: SDAI > 26 • Moderate disease activity: 11 to 26 • Low disease activity: 3.3 to 11 • Remission: ≤ 3.3. LOCF algorithm was used. The SDAI total score ranges from 0 to approximately 86.

ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Mean

Standard Error

units on a scale

Baseline and Weeks 1, 2, 4, 8, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.

Secondary

Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24

The CDAI is the SDAI modified to exclude CRP and is the sum of the 4 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), and Physician's Global Assessment of Disease Activity (in cm). The CDAI was be categorized as follows: • High disease activity: > 22 • Moderate disease activity: 10 to 22 • Mild disease activity: 2.8 to 10 • Remission: ≤ 2.8. LOCF algorithm was used. The CDAI total score ranges from 0 to approximately 76.

ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Mean

Standard Error

units on a scale

Baseline and Weeks 1, 2, 4, 8, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.

Secondary

Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24

FACIT-Fatigue scale is a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated that are scored reversely), the greater the fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating a better quality of life. LOCF algorithm was used.

ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Mean

Standard Error

units on a scale

Baseline and Weeks 4, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.

Secondary

Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24

The SF-36 is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). LOCF algorithm was used.

ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

Posted

Mean

Standard Error

units on a scale

Baseline and Weeks 4, 12, and 24

ID	Title	Description
OG000	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
OG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.

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	Placebo	Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.	0	86	4	86	11	86
EG001	GLPG0634 50 mg QD	Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.	0	82	0	82	23	82
EG002	GLPG0634 100 mg QD	Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	0	119	4	119	13	119
EG003	GLPG0634 200 mg QD	Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.	0	86	2	86	21	86
EG004	GLPG0634 25 mg BID	Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.	0	86	2	86	23	86
EG005	GLPG0634 50 mg BID	Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.	0	117	0	117	22	117
EG006	GLPG0634 100 mg BID	Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.	1	84	3	84	15	84

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG0030 affected86 at risk EG004
Pericardial effusion	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0021 affected119 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0021 affected119 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0021 affected119 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Abortion spontaneous complete	Pregnancy, puerperium and perinatal conditions	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Inflammation	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Appendicitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0021 affected119 at risk EG003
Diabetic gangrene	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0021 affected119 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0021 affected119 at risk EG003
Erysipelas	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected86 at risk EG0013 affected82 at risk EG0026 affected119 at risk EG0034 affected86 at risk EG0043 affected86 at risk EG0054 affected117 at risk EG0061 affected84 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected86 at risk EG0011 affected82 at risk EG0021 affected119 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected86 at risk EG0017 affected82 at risk EG0020 affected119 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0010 affected82 at risk EG0020 affected119 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0012 affected82 at risk EG0020 affected119 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected86 at risk EG0011 affected82 at risk EG0021 affected119 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0004 affected86 at risk EG0018 affected82 at risk EG0023 affected119 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected86 at risk EG0012 affected82 at risk EG0022 affected119 at risk EG003

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