Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 31 sites between 19 September 2002 and 13 January 2005.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 171 participants entered the Open-Label Lead-In (OL-LI) phase and received adalimumab. Of these 171 participants, 160 participants completed the OL-LI phase, and 133 participants entered the 32-week Double-Blind Phase (75 in the MTX stratum; 58 in the non-MTX stratum) and were randomized to adalimumab or placebo.

Reporting Groups

	Description
Double-Blind Adalimumab + MTX	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Placebo + MTX	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Adalimumab	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Double-Blind Placebo	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Open-Label Extension BSA Adalimumab + MTX	Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
Open-Label Extension BSA Adalimumab	Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
Open-Label Extension FD Adalimumab + MTX	Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Open-Label Extension FD Adalimumab	Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.

Participant Flow for 3 periods

Period 1:   Double-Blind Phase

	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX	Double-Blind Adalimumab	Double-Blind Placebo	Open-Label Extension BSA Adalimumab + MTX	Open-Label Extension BSA Adalimumab	Open-Label Extension FD Adalimumab + MTX	Open-Label Extension FD Adalimumab
STARTED	38 [1]	37	30	28	0	0	0	0
COMPLETED	35	36	29	28	0	0	0	0
NOT COMPLETED	3	1	1	0	0	0	0	0
Withdrawal by Subject	0	1	0	0	0	0	0	0
Protocol Violation	0	0	1	0	0	0	0	0
Sponsor request or decision	2	0	0	0	0	0	0	0
Randomized in error	1	0	0	0	0	0	0	0

Period 2:   Open-Label Extension BSA Phase

	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX	Double-Blind Adalimumab	Double-Blind Placebo	Open-Label Extension BSA Adalimumab + MTX	Open-Label Extension BSA Adalimumab	Open-Label Extension FD Adalimumab + MTX	Open-Label Extension FD Adalimumab
STARTED	0	0	0	0	71	57	0	0
COMPLETED	0	0	0	0	59	47	0	0
NOT COMPLETED	0	0	0	0	12	10	0	0
Withdrawal by Subject	0	0	0	0	3	6	0	0
Protocol Violation	0	0	0	0	0	1	0	0
Sponsor request or decision	0	0	0	0	5	1	0	0
Adverse Event	0	0	0	0	1	1	0	0
Lack of Efficacy	0	0	0	0	3	1	0	0

Period 3:   Open-Label Extension Fixed Dose Phase

	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX	Double-Blind Adalimumab	Double-Blind Placebo	Open-Label Extension BSA Adalimumab + MTX	Open-Label Extension BSA Adalimumab	Open-Label Extension FD Adalimumab + MTX	Open-Label Extension FD Adalimumab
STARTED	0	0	0	0	0	0	59	47
COMPLETED	0	0	0	0	0	0	37	25
NOT COMPLETED	0	0	0	0	0	0	22	22
Withdrawal by Subject	0	0	0	0	0	0	6	3
Protocol Violation	0	0	0	0	0	0	1	1
Sponsor request or decision	0	0	0	0	0	0	6	7
Adverse Event	0	0	0	0	0	0	2	2
Lack of Efficacy	0	0	0	0	0	0	2	1
Lost to Follow-up	0	0	0	0	0	0	5	8

Reporting Groups

	Description
Double-Blind Adalimumab + MTX	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Placebo + MTX	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Adalimumab	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Double-Blind Placebo	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.

Baseline Measures

	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX	Double-Blind Adalimumab	Double-Blind Placebo	Total
Number of Participants   [units: participants]	38	37	30	28	133
Age [1] [units: years] Mean ± Standard Deviation	11.7  ± 3.29	10.8  ± 3.36	11.1  ± 4.13	11.3  ± 3.77	11.2  ± 3.64
Gender [2] [units: Participants]
Female	30	30	23	20	103
Male	8	7	7	8	30

1.  Primary:

Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase   [ Time Frame: Week 16 to Week 48 (32 weeks) ]

2.  Secondary:

Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase   [ Time Frame: Week 16 ]

3.  Secondary:

Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase   [ Time Frame: Week 16 to Week 48 (32 Weeks) ]

4.  Secondary:

Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum   [ Time Frame: Week 16 to Week 48 (32 weeks) ]

5.  Secondary:

Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum   [ Time Frame: Week 16 to Week 48 (32 weeks) ]

6.  Secondary:

Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase   [ Time Frame: Week 48 ]

7.  Secondary:

Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase   [ Time Frame: Week 48 ]

8.  Secondary:

Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase   [ Time Frame: Week 48 ]

9.  Secondary:

Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase   [ Time Frame: Baseline and Week 48 ]

10.  Secondary:

Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase   [ Time Frame: Baseline and Week 48 ]

11.  Secondary:

Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase   [ Time Frame: Baseline and Week 48 ]

12.  Secondary:

Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase   [ Time Frame: Open-Label Lead-In Phase Baseline ]

13.  Secondary:

Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase   [ Time Frame: Week 56 ]

14.  Secondary:

Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase   [ Time Frame: Week 104 ]

15.  Secondary:

Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Baseline ]

16.  Secondary:

Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Week 48 ]

17.  Secondary:

Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Week 112 ]

18.  Secondary:

Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Final Visit (up to 224 weeks of OLE FD phase) ]

19.  Other Pre-specified:

Baseline Measure: Gender, Female/Male - OLE BSA Phase   [ Time Frame: Baseline OLE BSA Phase ]

20.  Other Pre-specified:

Baseline Measure: Age Continuous - OLE BSA Phase   [ Time Frame: Baseline OLE BSA Phase ]

21.  Other Pre-specified:

Baseline Measure: Gender, Female/Male - OLE FD Phase   [ Time Frame: Baseline OLE FD Phase ]

22.  Other Pre-specified:

Baseline Measure: Age Continuous - OLE FD Phase   [ Time Frame: Baseline OLE FD Phase ]